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TOTAL 510(k)s THIS PERIOD   224 TOTAL WITH SUMMARIES        212 TOTAL WITH STATEMENTS        12

DEVICE: PREFERRED BLOOD GLUCOSE MONITORING SYSTEM PRODIGY DIABETES CARE, LLC        510(k) NO: K122338(TRADITIONAL) ATTN: E.J.  SMITH                 PHONE NO : 888 729 9674   1468 HARWELL AVENUE               SE DECISION MADE: 05-NOV-13 CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNISTRIP 1 UNISTRIP TECHNOLOGIES, LLC        510(k) NO: K113135(TRADITIONAL) ATTN: E.J.  SMITH                 PHONE NO : 888 729 9674   1468 HARWELL AVE                  SE DECISION MADE: 06-NOV-13 CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST,  MIDSTREAM TEST AND DIP/CARD STRIP UCP BIOSCIENCES, INC.             510(k) NO: K131236(TRADITIONAL) ATTN: NANCY  CHEN                 PHONE NO : 408 392 0064   1445 KOLL CIRCLE, STE. 111        SE DECISION MADE: 07-NOV-13 SAN JOSE CA 95112                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV BECTON, DICKINSON AND COMPANY     510(k) NO: K132456(TRADITIONAL) ATTN: GREGORY P PAYNE, RAC        PHONE NO : 858 795 7890   10865 ROAD TO THE CURE SUITE 200  SE DECISION MADE: 07-NOV-13 SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS SIEMENS HELATHCARE DIAGNOSTICS INC510(k) NO: K131275(TRADITIONAL) ATTN: ELISABETH  WARINER          PHONE NO : 916 374 3183   1584 ENTERPRISE BLVD.             SE DECISION MADE: 08-NOV-13 WEST SACRAMENTO CA 95691          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS DIASORIN, INC.                    510(k) NO: K132515(TRADITIONAL) ATTN: CAROL A DEPOUW              PHONE NO : 651 351 5850   1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 08-NOV-13 STILLWATER MN 55082 0285          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM CO-INNOVATION BIOTECH CO., LTD.   510(k) NO: K132085(TRADITIONAL) ATTN: HONG  FENG                  PHONE NO : 86 20 62867285 NO. 13 YANYUAN ROAD. TIANHE DISTRISE DECISION MADE: 12-NOV-13 GUANGZHOU, GUANGDONG    CH 510507 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES OMEGA LABORATORIES, INC.          510(k) NO: K131128(TRADITIONAL) ATTN: ROBERT J BARD, JD           PHONE NO : 248 573 5040   400 NORTH CLEVELAND               SE DECISION MADE: 13-NOV-13 MOGADORE OH 44260                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GSP NEONATAL BIOTINIDASE KIT WALLAC OY                         510(k) NO: K131284(TRADITIONAL) ATTN: JEANETTE  SCHIER-PUGSLEY    PHONE NO : 781 663 6025   940 WINTER STREET                 SE DECISION MADE: 14-NOV-13 WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITEK 2 AST ST MEROPENEM BIOMERIEUX, INC.                  510(k) NO: K132507(TRADITIONAL) ATTN: NATHAN  HARDESTY            PHONE NO : 314 731 8666   595 ANGLUM RD.                    SE DECISION MADE: 15-NOV-13 HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ILLUMINA MISEQDX TM CYSTIC FIBROSIS CARRIER SCREEN ASSAY, ILLUMINA MISEQDX TM CYSTIC FIBROSIS DIAGNOSTIC ASSAY ILLUMINA, INC.                    510(k) NO: K124006(TRADITIONAL) ATTN: LEANNE M KIVIHARJU          PHONE NO : 858 202 4500   5200 ILLUMINA WAY                 SE DECISION MADE: 19-NOV-13 SAN DIEGO CA 92122                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ILLUMINA MISEQDX(TM) CYSTIC FIBROSIS DIAGNOSTIC ASSAY ILLUMINA, INC.                    510(k) NO: K132750(TRADITIONAL) ATTN: BRYAN  SCHNEIDER            PHONE NO : 858 202 4500   5200 ILLUMINA WAY                 SE DECISION MADE: 19-NOV-13 SAN DIEGO CA 92122                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR RANDOX LABORATORIES, LTD.         510(k) NO: K123977(TRADITIONAL) ATTN: PAULINE  ARMSTRONG          PHONE NO : 44 28 94422413 55 DIAMOND RD.                    SE DECISION MADE: 21-NOV-13 CRUMLIN, COUNTY ANTRIM    UK BT29 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFLAMMADRY EXTERNAL CONTROLS RAPID PATHOGEN SCREENING, INC.    510(k) NO: K132066(TRADITIONAL) ATTN: DOUGLAS  BUESCHEL           PHONE NO : 941 556 1850   7227 DELAINEY COURT               SE DECISION MADE: 21-NOV-13 SARASOTA FL 34240                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIRTUOSO SYSTEM FOR IHC ER (SPI) VENTANA MEDICAL SYSTEMS, INC.     510(k) NO: K130515(TRADITIONAL) ATTN: ERIKA  AMMIRATI             PHONE NO : 650 949 2768   575 SHIRLYNN COURT                SE DECISION MADE: 22-NOV-13 LOS ALTOS CA 94022                510(k) STATEMENT

DEVICE: GLB BENECHECK PREMIUM GLU MONITORING SYSTEM GENERAL LIFE BIOTECHNOLOGY CO., LT510(k) NO: K123090(TRADITIONAL) ATTN: FENG-YU  LEE                PHONE NO : 949 951 3046   27001 LA PAZ ROAD SUITE 266B      SE DECISION MADE: 22-NOV-13 MISSION VIEJO CA 92691            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K133067(TRADITIONAL) ATTN: KIRA  GORDON                PHONE NO : 914 524 2996   511 BENEDICT AVE                  SE DECISION MADE: 22-NOV-13 TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER, CARESENS N MULTI BLO I-SENS, INC.                      510(k) NO: K132288(SPECIAL) ATTN: CHAE YUN  LIM               PHONE NO : 822 91 66191 27-36 GWANGUN-RO, NOWON-GU        SE DECISION MADE: 22-NOV-13 SEOUL    KS 139-845               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRODIGY CHOICE PRODIGY DIABETES CARE, LLC        510(k) NO: K122340(TRADITIONAL) ATTN: E J  SMITH                  PHONE NO : 888 729 9674   1468 HARWELL AVENUE               SE DECISION MADE: 26-NOV-13 CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD MAX STAPHSR ASSAY, INSTRUMENT GENEOHM SCIENCES CANADA, INC. (BD 510(k) NO: K132822(TRADITIONAL) ATTN: PATRICIA  DIONNE            PHONE NO : 418 780778 3 2555 BOUL. DU PARC-TECHNOLOGIQUE  SE DECISION MADE: 26-NOV-13 QUEBEC    CA G1P 4S5              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM PRIMERADX                         510(k) NO: K132726(TRADITIONAL) ATTN: FAYYAZ  MEMNON              PHONE NO : 508 618 2300   171 FORBES BLVD SUITE 1000        SE DECISION MADE: 29-NOV-13 MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARPATH ALIGNER QSERVE AMERICA, INC.              510(k) NO: K123514(TRADITIONAL) ATTN: PATSY  TRISLER              PHONE NO : 301 652 5344   154 MAIN STREET, STE 2            SE DECISION MADE: 01-NOV-13 CHARLESTOWN NH 03603              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PETITE BASIC SYSTEM 701 ELT MEGO AFEK AC LTD                  510(k) NO: K131420(TRADITIONAL) ATTN: MARIA  GRIFFIN              PHONE NO : 516 482 9001   55 NORTHERN BLVD., STE 200        SE DECISION MADE: 01-NOV-13 GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SILK ROAD ACCESS CATHETER SILK ROAD MEDICAL, INC            510(k) NO: K130649(TRADITIONAL) ATTN: RICHARD M RUEDY             PHONE NO : 408 720 9002   735 NORTH PASTORIA AVE            SE DECISION MADE: 01-NOV-13 SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SCANNING LASERLINK LUMENIS, INC.                     510(k) NO: K130195(ABBREVIATED) ATTN: JACE R MCLANE               PHONE NO : 801 656 2328   3959 WEST 1820 SOUTH              SE DECISION MADE: 01-NOV-13 SALT LAKE CITY UT 84104           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND KURARAY NORITAKE DENTAL INC.      510(k) NO: K132450(TRADITIONAL) ATTN: MICHIO  TAKIGAWA            PHONE NO : 813 67 011706 OTE CENTER BLDG 7F 1-1-3, OTEMACHISE DECISION MADE: 01-NOV-13 CHIYODA-KU    JA 100-0004         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUIET/SILENT SCANNING SUITE SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132831(TRADITIONAL) ATTN: NADIA  SOOKDEO              PHONE NO : 610 448 4918   51 VALLEY STREAM PARKWAY          SE DECISION MADE: 01-NOV-13 MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K131669(TRADITIONAL) ATTN: LAUREN  KAMER               PHONE NO : 901 396 3133   1800 PYRAMID PLACE                SE DECISION MADE: 01-NOV-13 Memphis TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAYSCAN A-EXPERT RAY CO., LTD                      510(k) NO: K131693(SPECIAL) ATTN: ANDREW  PAENG               PHONE NO : 317 363 1000   4747 HOEN AVE.                    SE DECISION MADE: 01-NOV-13 SANTA ROSA CA 95405               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAYSCAN A-EXPERT 3D RAY CO., LTD                      510(k) NO: K131695(SPECIAL) ATTN: ANDREW  PAENG               PHONE NO : 317 363 1000   4747 HOEN AVE.                    SE DECISION MADE: 01-NOV-13 SANTA ROSA CA 95405               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENAMELAST ULTRADENT PRODUCTS INC. / ORATECH 510(k) NO: K132109(TRADITIONAL) ATTN: KAREN  KAKUNES              PHONE NO : 801 553 4366   505 W 10200 S                     SE DECISION MADE: 01-NOV-13 SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KLARITY VACUUM BAG, KLARITY MOLD CUSHION KLARITY MEDICAL PRODUCTS, LLC     510(k) NO: K132124(TRADITIONAL) ATTN: PETER  LARSON               PHONE NO : 740 788 8107   80 WESTGATE DRIVE                 SE DECISION MADE: 01-NOV-13 NEWARK OH 43055                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) HEMODIA S.A.S.                    510(k) NO: K132883(TRADITIONAL) ATTN: REMI  TEULIERE              PHONE NO : 33 561 007181 85 DU CHENE VERT                  SE DECISION MADE: 01-NOV-13 LABEGE    FR 31670                510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW AMBU A/S                          510(k) NO: K130845(TRADITIONAL) ATTN: SANJAY  PARIKH              PHONE NO : 410 768 6464   6740 BAYMEADOW DR.                SE DECISION MADE: 01-NOV-13 GLEN BURNIE MD 21060              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARIX HAND SYSTEM JEIL MEDICAL CORPORATION          510(k) NO: K131566(TRADITIONAL) ATTN: JI-EUN  KIM                 PHONE NO : 82 2 8503500 #702, KOLON SCIENCE VALLEY 2ND 811SE DECISION MADE: 04-NOV-13 SEOUL-CITY    KS 152-050          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES BOSTON SCIENTIFIC CORP.           510(k) NO: K131700(TRADITIONAL) ATTN: JANIS F TARANTO             PHONE NO : 508 683 4560   100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 04-NOV-13 MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGHTHOUSE(TM) URINARY CATHETER SEEDINGS LIFE SCIENCE VENTURES, LL510(k) NO: K131655(TRADITIONAL) ATTN: KEN  SOLOVAY                PHONE NO : 954 336 0777   230 EAST 15TH STREET SUITE 1-A    SE DECISION MADE: 04-NOV-13 NEW YORK NY 10003                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WOLF LONG BONE PLATE SYSTEM TOBY ORTHOPAEDICS                 510(k) NO: K131834(TRADITIONAL) ATTN: ERIC  NEYHARD               PHONE NO : 305 665 8699   401 SW 42nd Ave Suite 200         SE DECISION MADE: 04-NOV-13 Miami FL 33134                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MECTACER BIOLOX OPTION HEADS MEDACTA INTERNATIONAL             510(k) NO: K131518(TRADITIONAL) ATTN: ADAM  GROSS                 PHONE NO : 805 322 3289   4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 04-NOV-13 CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: X-PORTE ULTRASOUND SYSTEM FUJIFILM SONOSITE,INC.            510(k) NO: K133134(TRADITIONAL) ATTN: SCOTT  PAULSON              PHONE NO : 425 951 6926   21919 30th Dr SE                  SE DECISION MADE: 04-NOV-13 BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: CARDIOX FLOW DETECTION SYSTEM CARDIOX CORP.                     510(k) NO: K122400(TRADITIONAL) ATTN: KAREN  MATIS                PHONE NO : 614 791 8118   4100 HORIZONS DRIVE, SUITE 100    SE DECISION MADE: 05-NOV-13 COLUMBUS OH 43220                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DICOMPACS DX-R WITH FLAT PANEL OEHM UND REHBEIN GMBH             510(k) NO: K131211(TRADITIONAL) ATTN: FRANZISKA  GUENTHER         PHONE NO : 49 38136 600500 NEPTUNALLEE 7C                    SE DECISION MADE: 05-NOV-13 ROCKSTOCK    GM 18057             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIDA LED SURGICAL LIGHTING SYSTEM CONVIDA HEALTHCARE & SYSTEMS CORPO510(k) NO: K132307(TRADITIONAL) ATTN: RYAN  HUNG                  PHONE NO : 886 331837 77 2F AND B2, NO.33, DINGHU RD GUISHASE DECISION MADE: 05-NOV-13 TAOYUAN COUNTY    TW 33378        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEMILLS VALVULOTOME LEMAITRE VASCULAR, INC.           510(k) NO: K132047(TRADITIONAL) ATTN: ANDREW  HODGKINSON          PHONE NO : 781 221 2266   63 SECOND AVENUE                  SE DECISION MADE: 05-NOV-13 BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EM SINUS DILATION SYSTEM MEDTRONIC XOMED, INC.             510(k) NO: K132297(TRADITIONAL) ATTN: ROZANNE  PACIEJ             PHONE NO : 904 332 8233   6743 SOUTHPOINT DR. NORTH         SE DECISION MADE: 05-NOV-13 JACKSONVILLE FL 32216             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN COVIDIEN                          510(k) NO: K132567(SPECIAL) ATTN: DOLLY  MISTRY               PHONE NO : 508 452 1646   15 HAMPSHIRE STREET               SE DECISION MADE: 05-NOV-13 MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY – HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K132241(TRADITIONAL) ATTN: YAYORI  FUJIMAKI            PHONE NO : 508 828 3541   325 PARAMOUNT DR.                 SE DECISION MADE: 05-NOV-13 RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NURO NEUROMODULATION SYSTEM ADVANCED URO-SOLUTIONS, INC.      510(k) NO: K132561(TRADITIONAL) ATTN: PENNY  NORTHCUTT            PHONE NO : 678 428 6978   717 LAKEGLEN DRIVE                SE DECISION MADE: 05-NOV-13 SUWANEE GA 30024                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFUSION SYRINGE SET INNOVATIVE MEDICAL MANUFACTURING C510(k) NO: K131661(TRADITIONAL) ATTN: LUCY  HUANG                 PHONE NO : 011 886376 20236 107, LANE 181, SEC. 1 YONG JANE ROSE DECISION MADE: 05-NOV-13 CHUNAN, MIAOLI    TW 350          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH COVIDIEN LLC                      510(k) NO: K130357(TRADITIONAL) ATTN: KRISTEN  SWANSON            PHONE NO : 763 210 4062   161 CHESHIRE LANE STE 100         SE DECISION MADE: 06-NOV-13 MINNEAPOLIS MN 55441              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET TELEFLEX MEDICAL                  510(k) NO: K130405(TRADITIONAL) ATTN: LORI  PFOHL                 PHONE NO : 919 491 8960   2917 WECK DR.                     SE DECISION MADE: 06-NOV-13 RESEARCH TRIANGLE PARK NC 27709   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM GENORAY CO., LTD.                 510(k) NO: K130419(TRADITIONAL) ATTN: JAE  KIM                    PHONE NO : 855 436 6729   1073 N. BATAVIA ST                SE DECISION MADE: 06-NOV-13 ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEMAITRE 8F OCCLUSION CATHETER LEMAITRE VASCULAR, INC.           510(k) NO: K132022(TRADITIONAL) ATTN: ANDREW  HODGKINSON          PHONE NO : 781 221 2266   63 2ND AVENUE                     SE DECISION MADE: 06-NOV-13 BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET MOLNLYCKE HEALTH CARE US, LLC     510(k) NO: K132048(TRADITIONAL) ATTN: CURTIS D TRUESDALE          PHONE NO : 678 250 7829   5550 PEACHTREE PARKWAY SUITE 500  SE DECISION MADE: 06-NOV-13 NORCROSS GA 30092                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BELMONT HYPERTHERMIA PUMP BELMONT INSTRUMENT CORP.          510(k) NO: K131519(SPECIAL) ATTN: SABRINA  BELLADUE           PHONE NO : 978 663 0212   780 BOSTON RD.                    SE DECISION MADE: 06-NOV-13 BILLERICA MA 01821                510(k) STATEMENT

DEVICE: G-ARM MULTISCAN SYSTEM BEIJING EAST WHALE IMAGING TECHNOL510(k) NO: K131423(TRADITIONAL) ATTN: BETTER  LI                  PHONE NO : 86 10678 92701-838 NO. 2 WORKSHOP BLDG 2, NO 9 KECHUASE DECISION MADE: 07-NOV-13 BEIJING    CH 100023              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT COCHLEAR AMERICAS                 510(k) NO: K131240(TRADITIONAL) ATTN: SEAN  BUNDY                 PHONE NO : 800 523 5798   13059 EAST PEAKVIEW AVENUE        SE DECISION MADE: 07-NOV-13 CENTENNIAL CO 80111               510(k) STATEMENT

DEVICE: CONCEIVE PLUS SASMAR INC                        510(k) NO: K131355(TRADITIONAL) ATTN: JOHN-MICHAEL  MANCINI       PHONE NO : 773 942 0030   155 NORTH WACKER DR, STE 4250     SE DECISION MADE: 07-NOV-13 CHICAGO IL 60606                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE KIMBERLY-CLARK CORP.              510(k) NO: K131841(TRADITIONAL) ATTN: CHRISTINE L MACAULEY        PHONE NO : 770 587 8638    1400 HOLCOMB BRIDGE RD.           SE DECISION MADE: 07-NOV-13 ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUILION ONE VISION, V6.0 TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K132222(TRADITIONAL) ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   2441 MICHELLE DRIVE               SE DECISION MADE: 07-NOV-13 TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLARISO PACS CLARISO, INC.                     510(k) NO: K132799(TRADITIONAL) ATTN: CARL  ALLETTO               PHONE NO : 469 684 1980   111 MELANIE DRIVE                 SE DECISION MADE: 07-NOV-13 AUBREY TX 76227                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DC 7 DC INTERNATIONAL, LLC             510(k) NO: K131839(TRADITIONAL) ATTN: DAVID  BOEGLER              PHONE NO : 561 337 8888   624 CYPRESS GREEN CIR.            SE DECISION MADE: 07-NOV-13 WELLINGTON FL 33414               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASAPLP ASPIRATION CATHETER MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K132155(TRADITIONAL) ATTN: SUSAN  CHRISTENSEN          PHONE NO : 801 208 4789   1600 WEST MERIT PKWY.             SE DECISION MADE: 07-NOV-13 SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOALIGN PLUS SYSTEM ORTHALIGN, INC                    510(k) NO: K130387(TRADITIONAL) ATTN: AMY  WALTERS                PHONE NO : 949 923 9400   338 VISTA MADERA                  SE DECISION MADE: 08-NOV-13 NEWPORT BEACH CA 92660            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K-Y BRAND LIQUIBEADS JOHNSON & JOHNSON HEALTHCARE PRODU510(k) NO: K122061(TRADITIONAL) ATTN: LORNA-JANE  BREMER          PHONE NO : 973 385 0557   185 TABOR ROAD                    SE DECISION MADE: 08-NOV-13 MORRIS PLAINS NJ 07950            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BYTECH BYTECH DONGTAI CO., LTD.          510(k) NO: K130101(TRADITIONAL) ATTN: CHU  XIAOAN                 PHONE NO : 86 10 82387441 RM 1606 BUILDING 1 JIAN XIANG YUANSE DECISION MADE: 08-NOV-13 BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 GE HEALTHCARE                     510(k) NO: K132913(SPECIAL) ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   9900 W INNOVATION DRIVE           SE DECISION MADE: 08-NOV-13 WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APNEALINK PRO RESMED GERMANY INC.               510(k) NO: K131932(TRADITIONAL) ATTN: SANDRA  GRUNWALD            PHONE NO : 49 899 90100 FRAUNHOFERSTRASSE 16              SE DECISION MADE: 08-NOV-13 MARTINSRIED    GM D-82152         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM ORTHOSENSOR, INC.                 510(k) NO: K131767(SPECIAL) ATTN: MARTHA I GARAY              PHONE NO : 954 577 7770   1855 GRIFFIN ROAD SUITE A-310     SE DECISION MADE: 08-NOV-13 DANIA BEACH FL 33004 2200         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL            510(k) NO: K132574(TRADITIONAL) ATTN: AUDREY  VION                PHONE NO : 33 47 2018787 14 Porte du Grand Lyon            SE DECISION MADE: 08-NOV-13 NEYRON    FR 01700                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDIVALVE ACWIRE MEDIVALVE LTD.                    510(k) NO: K132545(TRADITIONAL) ATTN: LEO  BASTA                  PHONE NO : 617 834 9866   93 BENEFIT STREET                 SE DECISION MADE: 08-NOV-13 PROVIDENCE RI 02904               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HUMELOCK II CEMENTLESS SHOULDER SYSTEM FX SOLUTIONS                      510(k) NO: K130759(TRADITIONAL) ATTN: JEAN-JACQUES  MARTIN        PHONE NO : 33 474 553555 1663 RUE DE MAJORNAS              SE DECISION MADE: 09-NOV-13 VIRIAT    FR 01440                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAYMAN MI PLATE SYSTEM K2M, INC.                         510(k) NO: K131533(TRADITIONAL) ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   751 MILLER DR., S.E., SUITE F1    SE DECISION MADE: 09-NOV-13 Leesburg VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPECTRUM SPINE SPINOUS PROCESS DEVICE SPECTRUM SPINE IP HOLDINGS, LLC   510(k) NO: K130066(TRADITIONAL) ATTN: RICH  JANSEN                PHONE NO : 612 281 5505   13540 GUILD AVE                   SE DECISION MADE: 12-NOV-13 APPLE VALLEY MN 55124             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHANGHAI PHOENIX MECHANICAL WHEELCHAIR SHANGHAI PHOENIX MEDICAL EQUIPMENT510(k) NO: K130848(TRADITIONAL) ATTN: KE-MIN  JEN                 PHONE NO : 86 216722 1555 No.188, Zhongfa Road Zhujing IndusSE DECISION MADE: 12-NOV-13 Jinshan District, Shanghai    CN 2510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-CONTACT INFRARED THERMOMETER SHENZHEN JUMPER MEDICAL EQUIPMENT 510(k) NO: K131243(TRADITIONAL) ATTN: FIELD  FU                   PHONE NO : 86 755 86069197 4TH FLOOR, JINHUI BLDG, NANHAI BLVSE DECISION MADE: 12-NOV-13 SHENZHEN, GUANGDON    CH 518052   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I RUNE (I-200L) MEDIRUNE CO, LTD                  510(k) NO: K122410(TRADITIONAL) ATTN: YANG HO  DONG               PHONE NO : 082 256633 60 821 SAMIL PLAZA 837-26 YEUKSAM-DONSE DECISION MADE: 12-NOV-13 GANGNAM-GU    KS 135-768          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOGRAPH MMR SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133226(SPECIAL) ATTN: NADIA  SOOKDEO              PHONE NO : 610 448 4918   51 VALLEY STREAM PKWY.            SE DECISION MADE: 12-NOV-13 MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFINIX ANGIO WORKSTATION W/DTS SOFTWARE TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K132106(TRADITIONAL) ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   2441 MICHELLE DR.                 SE DECISION MADE: 12-NOV-13 TUSTIN CA 92780 2068              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS RADIOLOGY SOLUTIONS LLC           510(k) NO: K132294(TRADITIONAL) ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   8870 RAVELLO CT                   SE DECISION MADE: 12-NOV-13 NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUADROX-IR ADULT AND SMALL ADULT MAQUET CARDIOPULMONARY AG         510(k) NO: K133265(SPECIAL) ATTN: WHITNEY  TORNING            PHONE NO : 973 709 7994   45 BARBOUR POND DRIVE             SE DECISION MADE: 12-NOV-13 WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BECE CAD ZIRKON HT+ BEGO BREMER GOLDSCHLAEGEREI WILH. 510(k) NO: K132102(TRADITIONAL) ATTN: HEIKE  GUSTKE               PHONE NO : 49 421 2028112 WILHELM-HERBST-STRASSE 1          SE DECISION MADE: 12-NOV-13 BREMEN    GM 28359                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML HOSPIRA, INC.                     510(k) NO: K132276(TRADITIONAL) ATTN: ABIGAIL  FERGUSON           PHONE NO : 224 212 6162   275 NORTH FIELD DR.               SE DECISION MADE: 12-NOV-13 LAKE FOREST IL 60045              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KULAVAC CGBIO CO., LTD                    510(k) NO: K122490(TRADITIONAL) ATTN: JUNGEUN  IM                 PHONE NO : 822 205 91675 163-3 SAMSUNG-DONG KANGNAM-GU     SE DECISION MADE: 13-NOV-13 SEOUL    KS 135-715               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IDYS(TM) C CLARIANCE                         510(k) NO: K130853(TRADITIONAL) ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   1835 MARKET STREET 29TH FLOOR     SE DECISION MADE: 13-NOV-13 PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS MEDICAL DEVELOPMENTS INTERNATIONAL510(k) NO: K122252(TRADITIONAL) ATTN: TRACEY  BULLIVANT           PHONE NO : 612 990 62984 SUITE 408, 460 PACIFIC HIGHWAY    SE DECISION MADE: 13-NOV-13 ST LEONARDS    AS 2065            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA AMERIWATER                        510(k) NO: K131904(TRADITIONAL) ATTN: BRIAN R BOWMAN              PHONE NO : 937 461 8833   1303 STANLEY AVE.                 SE DECISION MADE: 13-NOV-13 DAYTON OH 45404                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U&U STERILE HYPODERMIC NEEDLE U&U MEDICAL TECHNOLOGY CO., LTD   510(k) NO: K132552(TRADITIONAL) ATTN: XUEBO  WANG                 PHONE NO : 86 1356 4751751 DONGZHOU VILLAGE, HENGSHANQIAO    SE DECISION MADE: 13-NOV-13 CHANGZHOU, JIANGSU    CH 213119   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B BECTON DICKINSON & CO.            510(k) NO: K133138(SPECIAL) ATTN: GREGORY P PAYNE             PHONE NO : 858 795 7890   10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 13-NOV-13 SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MERIDIAN AB ARDENT                         510(k) NO: K131753(ABBREVIATED) ATTN: DONNA MARIE  HARTNETT       PHONE NO : 716 691 0010   175 PINEVIEW DRIVE                SE DECISION MADE: 14-NOV-13 AMHERST NY 14228                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BOSCH BLOOD PRESSURE METER (BP5000 BT) ROBERT BOSCH HEALTHCARE SYSTEMS, I510(k) NO: K131026(TRADITIONAL) ATTN: LOUISE  MUSANTE             PHONE NO : 650 690 9167   2400 Geng Rd Ste 200              SE DECISION MADE: 14-NOV-13 Palo Alto CA 94303                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL ELECTROCARDIOGRAPHS SONOSCAPE COMPANY LIMITED         510(k) NO: K131262(TRADITIONAL) ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850 P.O. BOX 120-119                  SE DECISION MADE: 14-NOV-13 SHANGHAI    CH 237-023            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANKER DENTAL IMPLANT SYSTEM ALLIANCE GLOBAL                   510(k) NO: K131165(TRADITIONAL) ATTN: YAYUAN  CHANG               PHONE NO : 866 7695 6688 2F., NO.92, LUKE 5TH RD., LUZHU DISE DECISION MADE: 14-NOV-13 KAOHSIUNG CITY    TW 82151        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PEREGRINE CURVED ILLUMINATING LASER PROBE PEREGRINE SURGICAL, LTD.          510(k) NO: K132614(SPECIAL) ATTN: RYAN  O’LEARY               PHONE NO : 215 348 0456   51 Britain Drive                  SE DECISION MADE: 14-NOV-13 Doylestown PA 18901               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT MAQUET CARDIOVASCULAR LLC         510(k) NO: K131778(TRADITIONAL) ATTN: MARYLOU  INSINGA            PHONE NO : 973 709 7442   45 BARBOUR POND DRIVE             SE DECISION MADE: 14-NOV-13 Wayne NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORP.           510(k) NO: K133208(SPECIAL) ATTN: MAUREEN  SUNDEEN            PHONE NO : 763 494 2903    ONE SCIMED PLACE                  SE DECISION MADE: 14-NOV-13 MAPLE GROVE MN 55311 1566         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DOSIMETRY CHECK VERSION 4 RELEASE 1 MATH RESOLUTIONS, LLC.            510(k) NO: K132605(TRADITIONAL) ATTN: WENDEL  DEAN RENNER         PHONE NO : 410 997 9578   5975 GALES LN.                    SE DECISION MADE: 14-NOV-13 COLUMBIA MD 21045                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL COLOR DOPPLER ULTASOUND SYSTEM SONOSCAPE COMPANY LIMITED         510(k) NO: K132527(TRADITIONAL) ATTN: TOKI  WU                    PHONE NO : 86 755267 22890 YIZHE BLDG., YUQUAN RD            SE DECISION MADE: 14-NOV-13 SHENZHEN, GUANGDONG    CH 518051  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS IQ IMPLANTS LTD.                  510(k) NO: K130829(TRADITIONAL) ATTN: NATALIA  DINERSTHEIN        PHONE NO : 972 8 6233568 TAASHUR 9                         SE DECISION MADE: 14-NOV-13 OMER    IS 84965                  510(k) STATEMENT

DEVICE: MAGNETOM AERA SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132951(SPECIAL) ATTN: NADIA  SOOKDEO              PHONE NO : 610 448 4918   51 VALLEY STREAM PARKWAY          SE DECISION MADE: 15-NOV-13 MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPM-300 BIONET CO., LTD.                  510(k) NO: K130322(TRADITIONAL) ATTN: MARC  GOODMAN               PHONE NO : 949 398 5222   5405 ALTON PARKWAY, SUITE A530    SE DECISION MADE: 15-NOV-13 IRVINE CA 92604                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYMPHONY RF GENERATOR THERMIGEN, INC.                   510(k) NO: K130689(TRADITIONAL) ATTN: KEVIN  O’BRIEN              PHONE NO : 214 621 2525   401 N. CARROLL AVE                SE DECISION MADE: 15-NOV-13 SOUTHLAKE TX 76092                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEOVEIL GUNZE LIMITED                     510(k) NO: K130997(TRADITIONAL) ATTN: NOBUYA  ONISHI              PHONE NO : 817 734280 35 46 NATSUMEGAICHI, AONO            SE DECISION MADE: 15-NOV-13 AYABE, KYOTO    JA 623-8513       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOLITH TOUCH; URO TOUCH NORTHGATE TECHNOLOGIES INC.       510(k) NO: K130368(TRADITIONAL) ATTN: CASEY  KUREK                PHONE NO : 224 856 2222   1591 Scottsdale Court             SE DECISION MADE: 15-NOV-13 Elgin IL 60123                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSGATE GUIDE CATHETER STRYKER NEUROVASCULAR             510(k) NO: K132542(TRADITIONAL) ATTN: ANJALI  ATAL-GUPTA          PHONE NO : 510 413 2500   47900 BAYSIDE PARKWAY             SE DECISION MADE: 15-NOV-13 FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTRONIC PULSE MASSAGER SHENZHEN JINGKEHUI ELECTRONIC CO.,510(k) NO: K131921(TRADITIONAL) ATTN: BILL  DAI                   PHONE NO : 508 723 6334   513 PIAZZA DR. UNIT B             SE DECISION MADE: 15-NOV-13 MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHARPSOLOGY 2 INDUSTRIAL WATER SOLUTIONS, INC.  510(k) NO: K133031(TRADITIONAL) ATTN: THOMAS P STEWART            PHONE NO : 540 520 6341   2692 WILLOWLAWN STREET, S.W.      SE DECISION MADE: 15-NOV-13 Roanoke VA 24018                  510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T GE HEALTHCARE (GE MEDICAL SYSTEMS,510(k) NO: K132376(TRADITIONAL) ATTN: MICHELLE  HUETTNER          PHONE NO : 262 521 6102   3200 N. GRANDVIEW BLVD            SE DECISION MADE: 15-NOV-13 WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ND NABIL DIB INFUSION CATHETER TRANSLATIONAL RESEARCH INSTITUTE  510(k) NO: K130569(TRADITIONAL) ATTN: DEANN  DANA                 PHONE NO : 480 612 0640   3420 S MERCY RD #312              SE DECISION MADE: 15-NOV-13 GILBERT AZ 85297                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV BECTON DICKINSON & CO.            510(k) NO: K133140(SPECIAL) ATTN: GREGORY P PAYNE             PHONE NO : 858 795 7890   10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 15-NOV-13 SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROCYN SCAR MANAGEMENT HYDROGEL OCULUS INNOVATIVE SCIENCES        510(k) NO: K131672(TRADITIONAL) ATTN: BRIAN W MARTIN              PHONE NO : 707 283 0550   1129 N MCDOWELL BLVD              SE DECISION MADE: 15-NOV-13 PETALUMA CA 94954                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TENSYN BAND DALLEN MEDICAL, INC.              510(k) NO: K131850(TRADITIONAL) ATTN: AL  MEMMOLO                 PHONE NO : 949 218 0030   1046 Calle Recodo Ste G           SE DECISION MADE: 15-NOV-13 San Clemente CA 92673             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION VOLCANO CORPORATION               510(k) NO: K133142(SPECIAL) ATTN: ELAINE  ALAN                PHONE NO : 978 439 3357   1 FORTUNE DR                      SE DECISION MADE: 15-NOV-13 BILLERICA MA 01821                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM KCI USA, INC.                     510(k) NO: K132741(SPECIAL) ATTN: MELANIE  AVILA              PHONE NO : 210 515 4059   6203 FARINON DR.                  SE DECISION MADE: 15-NOV-13 SAN ANTONIO TX 78249              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) GE MEDICAL SYSTEMS, LLC           510(k) NO: K132261(TRADITIONAL) ATTN: JOHN L SCHMIDT              PHONE NO : 262 548 4964   3000 N GRANDVIEW BLVD.            SE DECISION MADE: 18-NOV-13 WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRITY SPINE CORE SYSTEM INTEGRITY SPINE                   510(k) NO: K132718(TRADITIONAL) ATTN: LISA  PETERSON              PHONE NO : 512 507 0746   14001 HUNTERS PASS                SE DECISION MADE: 18-NOV-13 AUSTIN TX 78734                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM) STRYKER SPINE                     510(k) NO: K132968(TRADITIONAL) ATTN: KRISTEN  MEANY, MS, CQA, RACPHONE NO : 201 760 8070   2 PEARL COURT                     SE DECISION MADE: 18-NOV-13 ALLENDALE NJ 07401                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRA FACET FIXATION SYSTEM SEASPINE, INC.                    510(k) NO: K132859(TRADITIONAL) ATTN: MICHELLE  WILLIS            PHONE NO : 760 216 5104   2302 LA MIRADA DR.                SE DECISION MADE: 18-NOV-13 VISTA CA 92081 7862               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5 AAP IMPLANTATE AG                 510(k) NO: K131782(TRADITIONAL) ATTN: CHRISTIAN  ZIETSCH          PHONE NO : 49 307501 9193 LORENZWEG 5                       SE DECISION MADE: 18-NOV-13 BERLIN    GM 12099                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLOWER ANKLE PLATING SET FLOWER ORTHOPEDICS CORPORATION    510(k) NO: K133102(TRADITIONAL) ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   1835 MARKET ST, 29TH FLOOR        SE DECISION MADE: 18-NOV-13 PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT ARTHROSURFACE, INC.               510(k) NO: K131377(TRADITIONAL) ATTN: DAWN J WILSON               PHONE NO : 508 520 3003   28 FORGE PARKWAY                  SE DECISION MADE: 19-NOV-13 FRANKLIN MA 02038                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUMITOMO PROTON THERAPY SYSTEM SUMITOMO HEAVY INDUSTRIES, LTD    510(k) NO: K130426(TRADITIONAL) ATTN: RONALD S WARREN             PHONE NO : 858 753 1961   11440 W. BERNARDO COURT SUITE 300 SE DECISION MADE: 19-NOV-13 SAN DIEGO CA 92127                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARACE MD EKOSCOPE IS100 PARACE LLC                        510(k) NO: K123148(TRADITIONAL) ATTN: VANDETTE  CARTER            PHONE NO : 914 356 4848   PO BOX 171                        SE DECISION MADE: 19-NOV-13 YORKTOWN HEIGHTS NY 10598         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM ZIMMER DENTAL INC.                510(k) NO: K132258(TRADITIONAL) ATTN: JULIE L CORMAN              PHONE NO : 760 929 4300   1900 ASTON AVE.                   SE DECISION MADE: 19-NOV-13 CARLSBAD CA 92008 7308            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER MEDTRONIC INC.                    510(k) NO: K132712(TRADITIONAL) ATTN: LISA  STONE                 PHONE NO : 763 514 9866   8200 CORAL SEA STREET NE          SE DECISION MADE: 19-NOV-13 MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K132779(TRADITIONAL) ATTN:                             PHONE NO : MINDRAY BLDG. KEJI 12TH RD S. HI-TSE DECISION MADE: 19-NOV-13 NANSHAN, SHENZHEN    CH 518057    510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS KCI USA, INC.                     510(k) NO: K133276(SPECIAL) ATTN: MELANIE  AVILA              PHONE NO : 210 515 4059   6203 FARINON DR.                  SE DECISION MADE: 19-NOV-13 SAN ANTONIO TX 78249              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A.L.P.S. CALCANEAL PLATING SYSTEM BIOMET MANUFACTURING CORP.        510(k) NO: K132898(TRADITIONAL) ATTN: JARED  COOPER               PHONE NO : 574 372 1941   56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 19-NOV-13 WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE WUXI YUSHOU MEDICAL APPLICANCES CO510(k) NO: K130212(TRADITIONAL) ATTN: GARFIELD  WANG              PHONE NO : 86 510 83777555 215# XIGANG ROAD DONGBEITANG      SE DECISION MADE: 20-NOV-13 WUXI CITY, JINGSU    CH 214191    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISIRONA MAGELLAN ISIRONA, LLC                      510(k) NO: K130707(TRADITIONAL) ATTN: THOMAS  KROENKE             PHONE NO : 303 956 4232   PO BOX 3018                       SE DECISION MADE: 20-NOV-13 NEDERLAND CO 80466                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES WUXI YUSHOU MEDICAL APPLICANCES CO510(k) NO: K130230(TRADITIONAL) ATTN: GARFIELD  WANG              PHONE NO : 86 510 83777555 215# XIGANG ROAD DONGBEITANG      SE DECISION MADE: 20-NOV-13 WUXI CITY, JIANGSU    CH 214191   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAMILTON-MR1 HAMILTON MEDICAL AG               510(k) NO: K122438(ABBREVIATED) ATTN: RALPH  AGUILA               PHONE NO : 418 166 06845 VIA CRUSCH 8                      SE DECISION MADE: 20-NOV-13 BONADUZ    SZ CH-7402             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WRIGHT GRADIENT 52 – TORSO WRIGHT THERAPY PRODUCTS, INC      510(k) NO: K131387(TRADITIONAL) ATTN: CAROL  WRIGHT               PHONE NO : 800 631 9535   103-B INTERNATIONAL DR.           SE DECISION MADE: 20-NOV-13 OAKDALE PA 15071                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MRI MARKER C4 IMAGING LLC                    510(k) NO: K131689(TRADITIONAL) ATTN: STEPHEN J GOLDNER, JD, RAC  PHONE NO : 248 747 8008   2550 SOUTH TELEGRAPH ROAD SUITE 10SE DECISION MADE: 20-NOV-13 BLOOMFIELD HILLS MI 48302         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONACO IMPAC MEDICAL SYSTEMS, INC.       510(k) NO: K132971(TRADITIONAL) ATTN: KATHRYN  STINSON            PHONE NO : 314 993 0003   13723 Riverport Drive Suite 100   SE DECISION MADE: 20-NOV-13 Maryland Heights MO 63139         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX SPINE SYSTEM SPINECRAFT LLC                    510(k) NO: K132603(TRADITIONAL) ATTN: AMI  AKALLAL-ASAAD          PHONE NO : 630 920 7300   777 OAKMONT LANE                  SE DECISION MADE: 20-NOV-13 WESTMONT IL 60559                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRONCHOSCOPY ELBOW RESPIRONICS, INC.                 510(k) NO: K132168(TRADITIONAL) ATTN: COLLEEN  WITT               PHONE NO : 724 387 4146   365 PLUM INDUSTRIAL COURT         SE DECISION MADE: 20-NOV-13 PITTSBURGH PA 15239               510(k) STATEMENT

DEVICE: I2C ION BEAM APPLICATIONS S.A.        510(k) NO: K132847(TRADITIONAL) ATTN: BRUCE D ARMON               PHONE NO : 215 972 7124   1500 MARKET STREET CENTRE SQUARE WSE DECISION MADE: 20-NOV-13 PHILADELPHIA PA 19102             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED, BEACON ENDOSCOPIC                 510(k) NO: K133008(TRADITIONAL) ATTN: ANNETTE M FAGNANT           PHONE NO : 617 965 7111   2000 Commonwealth Ave Ste 110     SE DECISION MADE: 20-NOV-13 Auburndale MA 02466               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTICAM 3000 ECO INTER MEDICAL MEDIZINTECHNIK GMBH 510(k) NO: K132347(TRADITIONAL) ATTN: WILLIAM  CARROLL            PHONE NO : 203 483 0665   14 COMMERCIAL ST, UNIT B          SE DECISION MADE: 20-NOV-13 BRANFORD CT 06405                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RETROARC RETROPUBIC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC.    510(k) NO: K132655(TRADITIONAL) ATTN: RENEE  MELLUM               PHONE NO : 952 930 6458   10700 BREN RD., WEST              SE DECISION MADE: 20-NOV-13 MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR WELCH ALLYN, INC.                 510(k) NO: K132808(SPECIAL) ATTN: KEVIN  CROSSEN              PHONE NO : 315 685 2609   4341 STATE ST. RD. P.O. BOX 220   SE DECISION MADE: 20-NOV-13 SKANEATELES FALLS NY 13153 0220   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AGAMATRIX HEALTH MANAGER AGAMATRIX INC                     510(k) NO: K132821(SPECIAL) ATTN: WILLIAM H MCGRAIL           PHONE NO : 603 328 6051   7C RAYMOND AVE                    SE DECISION MADE: 20-NOV-13 SALEM NH 03079                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NMI PICC III NAVILYST MEDICAL, INC.            510(k) NO: K133264(SPECIAL) ATTN: BRANDON  BRACKETT           PHONE NO : 508 658 7984   26 FOREST STREET                  SE DECISION MADE: 20-NOV-13 MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EDGE ORTHOPAEDICS BITE COMPRESSION SCREW ICON ORTHOPAEDIC CONCEPTS DBA EDGE510(k) NO: K132893(TRADITIONAL) ATTN: JAN  TRIANI                 PHONE NO : 201 543 9388   6 MARS COURT UNIT 6-3             SE DECISION MADE: 20-NOV-13 BOONTON NJ 07005                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVEREST SPINAL SYSTEM K2M, INC.                         510(k) NO: K132757(TRADITIONAL) ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   751 MILLER DR.,SE                 SE DECISION MADE: 20-NOV-13 LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFIX II SPINOUS PROCESS PLATE SYSTEM NUVASIVE, INCORPORATED            510(k) NO: K132411(TRADITIONAL) ATTN: OLGA  LEWIS                 PHONE NO : 858 320 5257   7475 LUSK BOULEVARD               SE DECISION MADE: 20-NOV-13 SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT AUDIFON-USA INC.                  510(k) NO: K130514(ABBREVIATED) ATTN: JANE E PERRONE              PHONE NO : 386 668 8812   403 CHAIRMAN COURT, STE. 1        SE DECISION MADE: 21-NOV-13 DEBARY FL 32713                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE PERSYST DEVELOPMENT CORP.         510(k) NO: K132306(TRADITIONAL) ATTN: DARI  DARABBEIGI            PHONE NO : 858 461 4542   12625 HIGH BLUFF DRIVE SUITE 213  SE DECISION MADE: 21-NOV-13 SAN DIEGO CA 92130                510(k) STATEMENT

DEVICE: MALDI BIOTYPER CA (MBT-CA) SYSTEM BRUKER DALTONICS, INC             510(k) NO: K130831(TRADITIONAL) ATTN: FRAN  WHITE                 PHONE NO : 978 927 3808   180 CABOT STREET                  SE DECISION MADE: 21-NOV-13 BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PC ECG EDAN INSTRUMENTS, INC.            510(k) NO: K131819(TRADITIONAL) ATTN: QUEENA  CHEN                PHONE NO : 867 55 26858736 EQUIPMENTS PARK, NANHAI RD 1019 NOSE DECISION MADE: 22-NOV-13 SHENZHEN    CH 518067             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REDSENSE ALARM SYSTEM REDSENSE MEDICAL AB               510(k) NO: K130554(TRADITIONAL) ATTN: PATRIK  BYHMER              PHONE NO : 49 7035 72164 GYLLENHAMMARS VAG 26              SE DECISION MADE: 22-NOV-13 HALMSTAD    SW 30292              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BREATH SHAKE CHEEN HOUNG ENT. CO. LTD.         510(k) NO: K121587(TRADITIONAL) ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   24301 WOODSAGE DRIVE              SE DECISION MADE: 22-NOV-13 BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OTOMAG BONE CONDUCATION HEARING SYSTEM SOPHONO, INC                      510(k) NO: K132189(TRADITIONAL) ATTN: KRISTA B TRAYNOR            PHONE NO : 720 407 5160   5744 CENTRAL AVENUE #100          SE DECISION MADE: 22-NOV-13 BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIEZON 150 E.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K132443(SPECIAL) ATTN: CYNTHIA  NOLTE              PHONE NO : 919 859 4207   62 FOREST ST., STE 300            SE DECISION MADE: 22-NOV-13 MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADHESIVE ELECTRODES TOP-RANK HEALTH CARE EQUIPMENT CO.510(k) NO: K132588(TRADITIONAL) ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850 P.O. BOX 120-119                  SE DECISION MADE: 22-NOV-13 SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOFIA DISTAL ACCESS CATHETER MICRO VENTION, INC.               510(k) NO: K131482(TRADITIONAL) ATTN: NAOMI  GONG                 PHONE NO : 714 247 8000   1311 VALENCIA AVENUE              SE DECISION MADE: 22-NOV-13 TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V8 TRANSLUMINAL BAV CATHETER INTERVALVE, INC                   510(k) NO: K132728(SPECIAL) ATTN: SEW-WAH  TAY                PHONE NO : 612 801 6782   84801 73RD AVENUE NORTH, SUITE 63 SE DECISION MADE: 22-NOV-13 MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SP-FIX SPINOUS PROCESS FIXATION PLATE GLOBE MEDICAL, INC.               510(k) NO: K132191(TRADITIONAL) ATTN: CHRISTINA  KICHULA          PHONE NO : 610 930 1800   2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 22-NOV-13 AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS CK-MB CALCHECK 5 ROCHE DIAGNOSTICS                 510(k) NO: K133284(TRADITIONAL) ATTN: KELLI  TURNER               PHONE NO : 317 521 4515   9115 HAGUE ROAD                   SE DECISION MADE: 22-NOV-13 INDIANAPOLIS IN 46250   46250     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRESCENT SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K133216(SPECIAL) ATTN: ANKIT K SHAH                PHONE NO : 800 876 3133    1800 PYRAMID PLACE                SE DECISION MADE: 22-NOV-13 MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V-STICK VASCULAR ACCESS SET ARGON MEDICAL                     510(k) NO: K130730(SPECIAL) ATTN: JENNIFER  BONACCI           PHONE NO : 352 519 5029   3600 SW 47TH AVE                  SE DECISION MADE: 22-NOV-13 GAINESVILLE FL 32608              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSE-4BABY SYSTEM SENSE4BABY, INC.                  510(k) NO: K132918(TRADITIONAL) ATTN: JACQUES  GINESTET           PHONE NO : 858 412 8605   3344 N. TORREY PINES COURT, STE 10SE DECISION MADE: 22-NOV-13 LA JOLLA CA 92037                 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: EASYCARE ONLINE RESMED LTD.                       510(k) NO: K132371(TRADITIONAL) ATTN: JIM  CASSI                  PHONE NO : 858 836 6081   9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 22-NOV-13 SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLARITY LPC LASER SYSTEM LUTRONIC CORPORATION              510(k) NO: K130199(TRADITIONAL) ATTN: JHUNG  WON VOJIR            PHONE NO : 215 205 2219   6 NESHAMINY INTERPLEX, SUITE 207  SE DECISION MADE: 22-NOV-13 TREVOSE PA 19053                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGNETOM PRISMA, MAGNETOM PRISMA FIT SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132119(TRADITIONAL) ATTN: NADIA  SOOKDEO              PHONE NO : 610 448 4918   51 VALLEY STREAM PKWY.            SE DECISION MADE: 22-NOV-13 MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOPTOUCH /OTHER CLIENTS PRIVATE LABELING JIANGSU TOPTOUCH GLOVE CO., LTD.  510(k) NO: K131826(TRADITIONAL) ATTN: CHU  XIAOAN                 PHONE NO : 86 10 82387441 RM 1606 BLDG, 1 JIAN XIANG YUAN NOSE DECISION MADE: 22-NOV-13 BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM CARDIOVASCULAR SYSTEMS INCORPORATE510(k) NO: K133399(SPECIAL) ATTN: BLAIR  BUTH                 PHONE NO : 651 259 2032   651 CAMPUS DR.                    SE DECISION MADE: 22-NOV-13 SAINT PAUL MN 55112               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DANA REUSABLE BI TEST PACK DANA PRODUCTS, INC.               510(k) NO: K130135(TRADITIONAL) ATTN: HARRY  BALA                 PHONE NO : 847 455 2881   7 COREY DR.                       SE DECISION MADE: 25-NOV-13 SOUTH BARINGTON IL 60010          510(k) STATEMENT

DEVICE: CAPNOMASK MEDIPLUS LTD.                     510(k) NO: K131339(TRADITIONAL) ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   24301 WOODSAGE DRIVE              SE DECISION MADE: 25-NOV-13 BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX COMPRESSION FT SCREWS ARTHREX, INC.                     510(k) NO: K132217(TRADITIONAL) ATTN: COURTNEY  SMITH             PHONE NO : 239 643 5553   1370 CREEKSIDE BOULEVARD          SE DECISION MADE: 25-NOV-13 NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLACK COLOURED CONDOM KAREX INDUSTRIES SDN BHD          510(k) NO: K132597(ABBREVIATED) ATTN: MARY  GOH YIN               PHONE NO : 607 688 1800 PTD. 7906/7907, TAMAN PONTIAN JAYASE DECISION MADE: 25-NOV-13 PONTIAN, JOHOR    MY 82000        510(k) STATEMENT

DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K132639(TRADITIONAL) ATTN: SHWETA  SHARMA              PHONE NO : 901 396 3133   1800 PYRAMID PLACE                SE DECISION MADE: 25-NOV-13 MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VAULT-C INTERVERTEBRAL BODY FUSION DEVICE EMPIRICAL TESTING CORPORATION     510(k) NO: K132029(TRADITIONAL) ATTN: MEREDITH  MAY               PHONE NO : 719 264 9937   4628 NORTHPARK DRVE               SE DECISION MADE: 25-NOV-13 COLORADO SPRINGS CO 80918         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIA / VITALITY ANALYZER IPGDX, LLC                        510(k) NO: K130856(TRADITIONAL) ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   33 GOLDEN EAGLE LANE              SE DECISION MADE: 25-NOV-13 LITTLETON CO 80127                510(k) STATEMENT

DEVICE: INBODY BIOSPACE CORPORATION LIMITED      510(k) NO: K130777(TRADITIONAL) ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234 1735   8870 RAVELLO CT                   SE DECISION MADE: 25-NOV-13 NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM ZIMMER SPINE, INC.                510(k) NO: K132884(TRADITIONAL) ATTN: JONATHAN  GILBERT           PHONE NO : 952 830 6385   7375 BUSH LAKE RD.                SE DECISION MADE: 25-NOV-13 MINNEAPOLIS MN 55439              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANAX 5.5 SPINAL SYSTEM U & I CORPORATION                 510(k) NO: K132101(TRADITIONAL) ATTN: YOUNG-GEUN  KIM             PHONE NO : 82 31 8520102 20, SANDAN-RO, 76BEON-GIL (RD)    SE DECISION MADE: 25-NOV-13 UIJEONGBU-SI, GYEONGGI-DO    KS 48510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM CORELINK LLC                      510(k) NO: K132504(TRADITIONAL) ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   1331 H STREET NW, 12TH FLOOR      SE DECISION MADE: 25-NOV-13 WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA TOMTEC IMAGING SYSTEMS, GMBH      510(k) NO: K132544(TRADITIONAL) ATTN: CHRISTINE  KLEIN            PHONE NO : 49 893217 5830 EDISONSTRASSE 6                   SE DECISION MADE: 25-NOV-13 UNTERSCHLEISSHEIM    GM D-85716   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FDR D-EVO FLAT PANEL DETECTOR SYSTEM FUJIFILM MEDICAL SYSTEMS USA, INC.510(k) NO: K132509(TRADITIONAL) ATTN: KATHERINE Y CHOI            PHONE NO : 203 602 3568   419 WEST AVENUE                   SE DECISION MADE: 25-NOV-13 STAMFORD CT 06902                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHARRUAPACS SYSTEM CHARRUASOFT SA                    510(k) NO: K133357(TRADITIONAL) ATTN: CARL  ALLETTO               PHONE NO : 469 684 1980   111 MELANIE DRIVE                 SE DECISION MADE: 25-NOV-13 AUBREY TX 76227                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VALVED TEARAWAY INTRODUCER GENERATION II MEDCOMP (MEDICAL COMPONENTS, INC.)510(k) NO: K132498(SPECIAL) ATTN: TIMOTHY  HOLWICK            PHONE NO : 215 256 4201   1499 DELP DR.                     SE DECISION MADE: 25-NOV-13 HARLEYSVILLE PA 19438             510(k) STATEMENT

DEVICE: NEURODYN MULTIWAVE, AUSSIE SPORT IBRAMED EQUIPAMENTOS MEDICOS      510(k) NO: K131629(TRADITIONAL) ATTN: LILIAN  LLULL               PHONE NO : 305 377 0077   18851 NE 29TH AVE 720             SE DECISION MADE: 26-NOV-13 AVENTURA FL 33180                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM EXACTECH, INC.                    510(k) NO: K131298(TRADITIONAL) ATTN: SHING JEN  TAI, PHD         PHONE NO : 352 377 1140   2320 N.W. 66TH CT.                SE DECISION MADE: 26-NOV-13 GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR SPS MEDICAL SUPPLY CORP.          510(k) NO: K122024(TRADITIONAL) ATTN: GARY J SOCOLA               PHONE NO : 585 359 0130   6789 W Henrietta Rd               SE DECISION MADE: 26-NOV-13 Industry NY 14543                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHASER V-MINI RX SHASER, INC.                      510(k) NO: K132170(TRADITIONAL) ATTN: ANTHONY  BURNS              PHONE NO : 781 995 2246   10 MAGUIRE ROAD                   SE DECISION MADE: 26-NOV-13 LEXINGTON MA 02421                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLAX DONGGUAN PRESTIGE SPORTING GOODS C510(k) NO: K131302(TRADITIONAL) ATTN: JUNNATA  CHANG              PHONE NO : 886 4 22465396 16F-2(16A), NO. 462, SEC. 2 CHONGDSE DECISION MADE: 26-NOV-13 TAICHUNG    TW 406                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC PHILIPS MEDIZIN SYSTEME BOEBLINGEN510(k) NO: K131913(ABBREVIATED) ATTN: MARKUS  STACHA              PHONE NO : 49 7031 4632840 HEWLETT-PACKARD STR. 2            SE DECISION MADE: 26-NOV-13 BOEBLINGEN, BW    GM D-71034      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE INFUSION SET SHANGHAI JINTA MEDICAL CO., LTD   510(k) NO: K131646(TRADITIONAL) ATTN: WANG  CHANGQING             PHONE NO : 021 6736 1700 NO. 18, JIANDING ROAD             SE DECISION MADE: 26-NOV-13 FENGJING TOWN, JINSHAN DISTRICT   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR JIANGSU HANDSAFE GLOVE CO., LTD.  510(k) NO: K131828(TRADITIONAL) ATTN: CHU  XIAOAN                 PHONE NO : 86 10 82387441 ROOM 1606 BLDG 1, JIAN XIANG YUAN SE DECISION MADE: 26-NOV-13 BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR JIANGSU HEALTHCARE PRODUCTS CO., L510(k) NO: K131831(TRADITIONAL) ATTN: CHU  XIAOAN                 PHONE NO : 86 10 82387441 ROOM 1606 BLDG 1, JIAN XIANG YUAN SE DECISION MADE: 26-NOV-13 BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CV3000 HOLTER ANALYSIS SYSTEM VALES & HILLS BIOMEDICAL TECH. LTD510(k) NO: K131897(TRADITIONAL) ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850 P.O. BOX 120-119                  SE DECISION MADE: 26-NOV-13 SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMOTION ECG MOBILE MEGA ELECTRONICS LTD.             510(k) NO: K131699(TRADITIONAL) ATTN: ANDRE  KINDSVATER           PHONE NO : 31 70 3458570 PRINSESSEGRACHT 20                SE DECISION MADE: 26-NOV-13 THE HAGUE    NL 2514 AP           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) TYRX , INC.                       510(k) NO: K132699(TRADITIONAL) ATTN: REGINA  NOVAK               PHONE NO : 732 964 1492   1 DEER PARK DR. SUITE G           SE DECISION MADE: 26-NOV-13 MONMOUTH JUNCTION NJ 08852        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERITEC GREEN CARD PACK BOWIE-DICK TEST STERITEC PRODUCTS MFG. CO., INC.  510(k) NO: K132372(TRADITIONAL) ATTN: JONATHAN  RUTIGLIANO        PHONE NO : 303 660 4201   74 INVERNESS DRIVE EAST           SE DECISION MADE: 26-NOV-13 ENGLEWOOD CO 80112                510(k) STATEMENT

DEVICE: NEWTRON BOOSTER SATELEC-ACTEON GROUP              510(k) NO: K131997(TRADITIONAL) ATTN: RICK  ROSATI                PHONE NO : 800 289 6367   124 GAITHER DRIVE , SUITE 140     SE DECISION MADE: 26-NOV-13 MT LAUREL NJ 08054                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM SPINEFRONTIER, INC.               510(k) NO: K132740(TRADITIONAL) ATTN: PAUL L SPEIDEL              PHONE NO : 978 232 3990   500 CUMMINGS CENTER SUITE 3500    SE DECISION MADE: 26-NOV-13 BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIATHLON TRITANIUM METAL-BACKED PATELLA STRYKER ORTHOPAEDICS              510(k) NO: K132624(TRADITIONAL) ATTN: SHIKHA  KHANDELWAL          PHONE NO : 201 831 6921   325 CORPORATE DRIVE               SE DECISION MADE: 26-NOV-13 MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN ROCHE DIAGNOSTICS                 510(k) NO: K133330(SPECIAL) ATTN: SUSAN  HOLLANDBECK          PHONE NO : 317 521 3380   9115 SOUTH HAGUE ROAD             SE DECISION MADE: 26-NOV-13 INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KNIT-PAK+ PREMIER DENTAL PRODUCTS CO.       510(k) NO: K132526(TRADITIONAL) ATTN: VINCENT  D’ALLESANDRO       PHONE NO : 610 239 6000   1710 ROMANO DR.                   SE DECISION MADE: 26-NOV-13 PLYMOUTH MEETING PA 19462         510(k) STATEMENT

DEVICE: FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K131369(TRADITIONAL) ATTN: LEIGH  SPOTTEN              PHONE NO : 424 218 8738   2151 E. GRAND AVENUE              SE DECISION MADE: 26-NOV-13 EL SEGUNDO CA 90245               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CYBERWAND STERILE PROBE SET CYBERSONICS, INC.                 510(k) NO: K132795(SPECIAL) ATTN: LORI  COLVIN                PHONE NO : 814 898 4734   5325 KUHL RD.                     SE DECISION MADE: 26-NOV-13 Erie PA 16510                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASPIRE RX-LP6 ASPIRATION CATHETER CONTROL MEDICAL TECHNOLOGY, LLC   510(k) NO: K131998(TRADITIONAL) ATTN: SHAWN  FOJTIK               PHONE NO : 435 602 9640   136 HEBER AVENUE, SUITE 101 PO BOXSE DECISION MADE: 26-NOV-13 PARK CITY UT 84068                510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: GENESIS LED WANDS GENESIS BIOSYSTEMS, INC.          510(k) NO: K131142(TRADITIONAL) ATTN: JIM  LAFFERTY               PHONE NO : 972 315 7888   1500 EAGLE COURT                  SE DECISION MADE: 27-NOV-13 LEWISVILLE TX 75057               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JUSHA-M52C MEDICAL DISPLAY NANJING JUSHA DISPLAY TECHNOLOGY C510(k) NO: K131390(TRADITIONAL) ATTN: MIKE  GU                    PHONE NO : 86 20 62321333 7TH FLOOR, 982. CONGYUN RD. BAIYUNSE DECISION MADE: 27-NOV-13 GUANGZHOU, GUANGDONG    CH 510420 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARCHON ANTERIOR CERVICAL PLATE SYSTEM NUVASIVE, INC.                    510(k) NO: K131025(TRADITIONAL) ATTN: CYNTHIA  ADAMS              PHONE NO : 858 320 4549   7475 LUSK BLVD                    SE DECISION MADE: 27-NOV-13 SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROGS MOLECULAR PRODUCTS LTD.           510(k) NO: K131016(SPECIAL) ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   24301 WOODSAGE DR.                SE DECISION MADE: 27-NOV-13 BONITA SPRINGS FL 34134 2958      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE ADVANCED BRAIN MONITORING INC.    510(k) NO: K131383(TRADITIONAL) ATTN: ADRIENNE  LENZ              PHONE NO : 262 290 0023   W324 S3649 COUNTY ROAD E          SE DECISION MADE: 27-NOV-13 DOUSMAN WI 53118                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) PEGA MEDICAL INC.                 510(k) NO: K131591(TRADITIONAL) ATTN: ARIEL R DUJOVNE             PHONE NO : 450 688514 4 1111 AUTOROUTE CHOMEDEY           SE DECISION MADE: 27-NOV-13 LAVAL    CA H7W 5J8               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TITLE 2 POLYAXIAL SPINAL SYSTEM ZIMMER SPINE, INC.                510(k) NO: K133086(TRADITIONAL) ATTN: MICHELLE  LENZ              PHONE NO : 952 830 6243   7375 BUSH LAKE RD.                SE DECISION MADE: 27-NOV-13 MINNEAPOLIS MN 55439              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESPIN SYSTEM NLT SPINE LTD                     510(k) NO: K133061(TRADITIONAL) ATTN: JOHN J SMITH                PHONE NO : 202 637 3638   555 13TH ST NW                    SE DECISION MADE: 27-NOV-13 WASHINGTON DC 20004   20004       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM REVERSE MEDICAL CORPORATION       510(k) NO: K133282(SPECIAL) ATTN: JEFFREY  VALKO              PHONE NO : 949 215 0660   13700 Alton Parkway Suite 167     SE DECISION MADE: 27-NOV-13 Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYLABSEVEN, MYLABALPHA ESAOTE, S.P.A.                    510(k) NO: K132231(TRADITIONAL) ATTN: ALLISON  SCOTT              PHONE NO : 317 569 9500   9001 WESLEYAN ROAD SUITE 200      SE DECISION MADE: 27-NOV-13 INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR ZIBO INTCO MEDICAL PRODUCTS CO., L510(k) NO: K132201(TRADITIONAL) ATTN: JOHN  ZHAO                  PHONE NO : 909 548 4828   12390 EAST END AVE.               SE DECISION MADE: 27-NOV-13 CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-CUBE 7 ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K132687(TRADITIONAL) ATTN: DONGHWAN  KIM               PHONE NO : 82 70 74652068 1, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 27-NOV-13 SEOUL    KS 152-848               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIP MIS INTERSPINOUS FUSION SYSTEM AURORA SPINE                      510(k) NO: K133091(TRADITIONAL) ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   331 H STREET NW, 12TH FL.         SE DECISION MADE: 27-NOV-13 WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD          510(k) NO: K133329(TRADITIONAL) ATTN: PARK  KYEONG-MI             PHONE NO : 42, TEHERAN-RO 108-GIL GANGNAM-GU SE DECISION MADE: 27-NOV-13 SEOUL    KS                       510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS TELEFLEX MEDICAL                  510(k) NO: K132658(TRADITIONAL) ATTN: ASHLEA  RICCI, RAC          PHONE NO : 919 433 8065   2917 WECK DR.                     SE DECISION MADE: 27-NOV-13 RESEARCH TRIANGLE PARK NC 27709   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPECULAR MICROSCOPE CEM-530 NIDEK CO., LTD.                   510(k) NO: K130565(TRADITIONAL) ATTN: ARON  SHAPIRO               PHONE NO : 978 685 8900   300 BRICKSTONE SQUARE             SE DECISION MADE: 27-NOV-13 ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIEZOSURGERY FLEX MECTRON S.P.A.                    510(k) NO: K132848(TRADITIONAL) ATTN: ROGER  GRAY                 PHONE NO : 39 06 5782665 PIAZZA ALBANIA 10                 SE DECISION MADE: 29-NOV-13 ROME    IT 00153                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INOMAX DSIR (DELIVERY SYSTEM) INO THERAPEUTICS/IKARIA           510(k) NO: K131686(TRADITIONAL) ATTN: ROBERT  BOVY                PHONE NO : 608 226 3450   2902 DAIRY DRIVE                  SE DECISION MADE: 29-NOV-13 MADISON WI 53718                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LESSRAY SAFERAY SPINE, LLC                510(k) NO: K132970(SPECIAL) ATTN: CALLEY  HERZOG              PHONE NO : 720 883 3633   400 N. WASHINGTON ST., STE 100    SE DECISION MADE: 29-NOV-13 ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANQUILL BARBED DEVICE SURGICAL SPECIALTIES CORP. DBA ANG510(k) NO: K133420(SPECIAL) ATTN: KIRSTEN  STOWELL            PHONE NO : 610 404 3367   100 DENNIS DR.                    SE DECISION MADE: 29-NOV-13 Reading PA 19606                  510(k) SUMMARY AVAILABLE FROM FDA

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance

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