Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Medical Devices

July 2013 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD July 2013


DEVICE: FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS
QUALIGEN, INC.                    510(k) NO: K123983(TRADITIONAL)
ATTN: MICHAEL S POIRIER           PHONE NO : 760 918 9165   
2042 CORTE DEL NOGAL SUITE B      SE DECISION MADE: 03-JUL-13
CARLSBAD CA 92011 1438            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
THE BINDING SITE GROUP, LTD.      510(k) NO: K123256(TRADITIONAL)
ATTN: JILL  CONSTANTINE           PHONE NO : 440 121456 9500
8 CALTHORPE ROAD EDGBASTON        SE DECISION MADE: 03-JUL-13
BIRMINGHAM, WEST MIDLANDS    UK B1510(k) STATEMENT

DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)
BECTON, DICKINSON & CO.           510(k) NO: K131331(TRADITIONAL)
ATTN: MONICA E GIGUERE            PHONE NO : 410 316 4287   
7 LOVETON CIR.                    SE DECISION MADE: 10-JUL-13
SPARKS MD 21152 0999              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
MICROGENICS CORP.                 510(k) NO: K123343(TRADITIONAL)
ATTN: KAREN  LEE                  PHONE NO : 510 979 5000   
46360 FREMONT BLVD                SE DECISION MADE: 11-JUL-13
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANA SCREEN ELISA (IGG)
EUROIMMUN US                      510(k) NO: K131185(TRADITIONAL)
ATTN: MICHAEL  LOCKE              PHONE NO : 973 656 1000   
1100 THE AMERICAN ROAD            SE DECISION MADE: 15-JUL-13
MORRIS PLAINS NJ 07950            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 25OH VITAMIN D TOTAL ELISA TEST
DIASOURCE IMMUNOASSAYS, S.A.      510(k) NO: K123364(TRADITIONAL)
ATTN: NAPOLEON  MONCE             PHONE NO : 530 759 8000   
2851 SPAFFORD ST                  SE DECISION MADE: 15-JUL-13
DAVIS CA 95618                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EUROIMMUN 25-OH  VITAMIN D ELISA
EUROIMMUN US                      510(k) NO: K123660(TRADITIONAL)
ATTN: KATHRYN  KOHL               PHONE NO : 973 656 1000   
1100 THE AMERICAN ROAD            SE DECISION MADE: 17-JUL-13
MORRIS PLAINS NJ 07950            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMDX VANR FOR ABBOTT M2000
INTELLIGENT  MEDICAL  DEVICES,  IN510(k) NO: K123753(TRADITIONAL)
ATTN: FRAN  WHITE                 PHONE NO : 978 927 3808   
180 CABOT ST.                     SE DECISION MADE: 17-JUL-13
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
UCP BIOSCIENCES, INC.             510(k) NO: K131811(SPECIAL)
ATTN: NANCY  CHEN                 PHONE NO : 408 392 0064   
1445 KOLL CIRCLE, STE. 111        SE DECISION MADE: 19-JUL-13
SAN JOSE CA 95112                 510(k) STATEMENT

DEVICE: GRAM-NEGATIVE QUICKFISH BC
ADVANDX, INC.                     510(k) NO: K123418(TRADITIONAL)
ATTN: BENJAMIN S CRYSTAL          PHONE NO : 781 376 0009   
400 TradeCenter Suite 6990        SE DECISION MADE: 21-JUL-13
WOBURN MA 01801                   510(k) STATEMENT

DEVICE: CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
CHEMTRON BIOTECH, INC.            510(k) NO: K131931(TRADITIONAL)
ATTN: JANE  ZHANG                 PHONE NO : 858 530 2868   
8370 JUNIPER CREEK LANE SUITE 1-2 SE DECISION MADE: 26-JUL-13
SAN DIEGO CA 92126                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT
SEBIA                             510(k) NO: K130500(TRADITIONAL)
ATTN: KAREN  ANDERSON             PHONE NO : 800 835 6497   
1705 CORPORATE DRIVE SUITE 400    SE DECISION MADE: 26-JUL-13
DULUTH GA 30093                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K131754(TRADITIONAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 31-JUL-13
GAITHERSBURG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
INFOPIA CO., LTD                  510(k) NO: K130181(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 844 2612   
1515 E KATELLA AVE UNIT 2115      SE DECISION MADE: 31-JUL-13
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JBAIDS PLAGUE DETECTION KIT
BIOFIRE DIAGNOSTICS, INC.         510(k) NO: K131729(TRADITIONAL)
ATTN: CYNTHIA  PHILLIPS           PHONE NO : 801 736 6354   
390 WAKARA WAY                    SE DECISION MADE: 31-JUL-13
Emigration Canyon UT 84108        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JBAIDS TULAREMIA DETECTION KIT
BIOFIRE DIAGNOSTICS, INC.         510(k) NO: K131936(TRADITIONAL)
ATTN: CYNTHIA  PHILIPS            PHONE NO : 801 736 6354   
390 WAKARA WAY                    SE DECISION MADE: 31-JUL-13
SALT LAKE CITY UT 84108           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEATER-COOLER UNIT HCU 40
MAQUET CARDIOPULMONARY AG         510(k) NO: K130300(TRADITIONAL)
ATTN: HELDER A SOUSA              PHONE NO : 973 709 7465   
45 BARBOUR POND DRIVE             SE DECISION MADE: 01-JUL-13
WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ERA MICRO 23  FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT
STERNGOLD DENTAL LLC              510(k) NO: K130408(ABBREVIATED)
ATTN: MARIA  RAO                  PHONE NO : 508 226 5660   
23 Frank Mossberg Drive           SE DECISION MADE: 01-JUL-13
Attleboro MA 02703                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELLEX 2RT
ELLEX MEDICAL PTY. LTD.           510(k) NO: K122202(TRADITIONAL)
ATTN: KEVIN  HOWARD               PHONE NO : 618 810 45200
82 GILBERT ST.                    SE DECISION MADE: 01-JUL-13
ADELAIDE, SOUTH AUSTRALIA    AS 50510(k) STATEMENT

DEVICE: COOK HOLMIUM LASER FIBER
COOK INCORPORATED                 510(k) NO: K124030(SPECIAL)
ATTN: CONNIE  RICE                PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 01-JUL-13
BLOOMINGTON IN 47404              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
PIPELINE ORTHOPEDICS              510(k) NO: K130353(TRADITIONAL)
ATTN: TERRY  POWELL               PHONE NO : 703 562 9800   
901 KING STREET, SUITE 200        SE DECISION MADE: 01-JUL-13
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CIRONA DVT FOOT GARMENT
DEVON MEDICAL INC.                510(k) NO: K131743(TRADITIONAL)
ATTN: RUTH  WU                    PHONE NO : 610 757 4103   
1100 1ST AVENUE SUITE 100         SE DECISION MADE: 01-JUL-13
KING OF PRUSSIA PA 19406          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K131705(SPECIAL)
ATTN: KATHERINE  ROBERTSON        PHONE NO : 203 492 5299   
60 Middletown Ave                 SE DECISION MADE: 01-JUL-13
North Haven CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROCELLERA
VOMARIS INNOVATIONS INC.          510(k) NO: K130350(TRADITIONAL)
ATTN: JEFFRY  SKIBA               PHONE NO : 480 921 4948   
3100 W. Ray Rd, Ste 148           SE DECISION MADE: 02-JUL-13
Chandler AZ 85226                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MDK MULTI-APPLICATIONS PLATFORM
QUANTA SYSTEM SPA                 510(k) NO: K130256(TRADITIONAL)
ATTN: MAURIZIO  BIANCHI           PHONE NO : 390 331376 797
VIA IV NOVEMBRE 116               SE DECISION MADE: 02-JUL-13
SOLBIATE OLONA (VA)    IT 21058   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER
MERCATOR MEDSYSTEMS, INC.         510(k) NO: K131401(TRADITIONAL)
ATTN: PLAMENA  ENTCHEVA-DIMITROV, PHONE NO : 510 614 4550   
1670 ALVARADO SUITE #4            SE DECISION MADE: 02-JUL-13
SAN LEANDRO CA 94577              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VIDA PTV DILATATON CATHETER
C.R. BARD, INC.                   510(k) NO: K131002(TRADITIONAL)
ATTN: AARON  CONOVALOFF           PHONE NO : 480 350 6012   
1625 WEST 3RD ST.                 SE DECISION MADE: 02-JUL-13
TEMPE AZ 85281 1740               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFIX SPINOUS PROCESS PLATE SYSTEM
NUVASIVE, INC.                    510(k) NO: K131238(TRADITIONAL)
ATTN: SHEILA  BRUSCHI             PHONE NO : 858 320 4515   
7475 LUSK BLVD                    SE DECISION MADE: 02-JUL-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSUS
NEUROMETRIX, INC.                 510(k) NO: K130919(TRADITIONAL)
ATTN: RAINER  MAAS                PHONE NO : 781 314 2781   
62 FOURTH AVE.                    SE DECISION MADE: 02-JUL-13
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORRECT PLUS 1
PENTRON CLINICAL                  510(k) NO: K130920(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 02-JUL-13
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHROCARE TURBINATOR WAND
ARTHROCARE CORPORATION            510(k) NO: K122652(TRADITIONAL)
ATTN: CHERYL  FREDERICK           PHONE NO : 512 358 5751   
7000 W William Cannon Dr          SE DECISION MADE: 02-JUL-13
Austin TX 78735                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
REVERSE MEDICAL CORPORATION       510(k) NO: K123803(TRADITIONAL)
ATTN: JEFFREY  VALKO              PHONE NO : 949 215 0660   
13700 ALTON PARKWAY SUITE 167     SE DECISION MADE: 02-JUL-13
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA
RAYENCE CO., LTD                  510(k) NO: K130935(TRADITIONAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 02-JUL-13
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOBIS II
SIGNUS MEDIZINTECHNIK GMBH        510(k) NO: K131372(TRADITIONAL)
ATTN: KAREN E WARDEN              PHONE NO : 440 729 8457   
PO BOX 566                        SE DECISION MADE: 02-JUL-13
CHESTERLAND OH 44026 2141         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM
LINVATEC CORPORATION D/B/A CONMED 510(k) NO: K131035(SPECIAL)
ATTN: JOY  LOVETT                 PHONE NO : 727 399 5137   
11311  Concept Boulevard          SE DECISION MADE: 02-JUL-13
LARGO FL 33773                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEWTOM VGI AND NEWTOM 5G
QR S.R.L.                         510(k) NO: K130442(TRADITIONAL)
ATTN: BERTHOIN  CLAUDE            PHONE NO : 386 672 2630   
110 E. GRANADA BLVD. SUITE 207    SE DECISION MADE: 03-JUL-13
ORMOND BEACH FL 32176             510(k) STATEMENT

DEVICE: DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
INTERNATIONAL TECHNIDYNE CORP.    510(k) NO: K120977(TRADITIONAL)
ATTN: LAWRENCE  PICCIANO          PHONE NO : 732 548 5700   
23 NEVSKY ST.                     SE DECISION MADE: 03-JUL-13
EDISON NJ 08820                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 2008K@HOME HEMODIALYSIS MACHINE
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K124035(TRADITIONAL)
ATTN: DENISE  OPPERMANN           PHONE NO : 781 699 4479   
920 WINTER STREET                 SE DECISION MADE: 03-JUL-13
WALTHAM MA 02451 1457             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS,
CANON INC.                        510(k) NO: K131106(TRADITIONAL)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480 9554   
1201 RICHARDSON DRIVE, SUITE 280  SE DECISION MADE: 03-JUL-13
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABSOCLEAR
PHARMAPLAST S.A.E.                510(k) NO: K130553(TRADITIONAL)
ATTN: CYNTHIA  PRITCHARD          PHONE NO : 919 676 6185   
1016 TOBIANO LANE                 SE DECISION MADE: 03-JUL-13
RALEIGH NC 27614                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH
HERTART                           510(k) NO: K123641(TRADITIONAL)
ATTN: HENRIK  DORGE               PHONE NO : 453 691 5170
KORSKILDELUND 6                   SE DECISION MADE: 03-JUL-13
GREVE    DA 2670                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K123074(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 949 706 7456   
55 NORTHERN BLVD., SUITE 200      SE DECISION MADE: 03-JUL-13
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM
LASERSTIM, INC.                   510(k) NO: K123177(TRADITIONAL)
ATTN: DAVID C FURR                PHONE NO : 512 906 9654   
8708 CAPEHART COVE                SE DECISION MADE: 03-JUL-13
AUSTIN TX 78733                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT
HORIBA ABX S.A.S.                 510(k) NO: K123171(ABBREVIATED)
ATTN: CAROLINE  FERRER            PHONE NO : 330 4 67141843
PARC EUROMEDECINE RUE DU CADUCEE-BSE DECISION MADE: 03-JUL-13
MONTPELLIER CEDEX 4, HERAULT    FR510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
MENICON CO. LTD.                  510(k) NO: K130805(TRADITIONAL)
ATTN: ELLEN M BEUCLER             PHONE NO : 978 658 6888   
187 BALLARDVALE STREET SUITE 180  SE DECISION MADE: 03-JUL-13
WILMINGTON MA 01887               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IFUSION
OPTOVUE, INC.                     510(k) NO: K130656(SPECIAL)
ATTN: WILLIAM "BILL"  JACKSON     PHONE NO : 510 623 8868   
2800 Bayview Dr                   SE DECISION MADE: 03-JUL-13
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CYBER TM FAMILY
QUANTA SYSTEM SPA                 510(k) NO: K131081(TRADITIONAL)
ATTN: MAURIZIO  BIANCHI           PHONE NO : 39 0331 376797
VIA IV NOVEMBRE, 116              SE DECISION MADE: 03-JUL-13
SOLBIATE OLONA (VA)    IT 21058   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 2MP COLOR LCD MONITOR, RADIFORCE MX215
EIZO CORPORATION                  510(k) NO: K131090(TRADITIONAL)
ATTN: HIROAKI  HASHIMOTO          PHONE NO : 81 76 2742468
153 SHIMOKASHIWANO                SE DECISION MADE: 03-JUL-13
HAKUSAN, ISHIKAWA    JA 924-8566  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNASTY ACETABULAR SYSTEM WITH CERAMIC
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K130376(TRADITIONAL)
ATTN: DEAN  NACHTRAB              PHONE NO : 901 290 5812   
5677 AIRLINE RD.                  SE DECISION MADE: 03-JUL-13
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT
EXACTECH, INC.                    510(k) NO: K131575(SPECIAL)
ATTN: PATRICK  HUGHES             PHONE NO : 352 327 4762   
2320 N.W. 66TH CT.                SE DECISION MADE: 03-JUL-13
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM
EMERGE MEDICAL                    510(k) NO: K131480(TRADITIONAL)
ATTN: VICTORIA  TRAFKA            PHONE NO : 303 225 7909   
790 S. COLORADO BLVD SUITE 550-S  SE DECISION MADE: 03-JUL-13
DENVER CO 80246                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CP150 ELECTROCARDIOGRAPH
WELCH ALLYN, INC.                 510(k) NO: K131573(SPECIAL)
ATTN: KEVIN  CROSSEN              PHONE NO : 315 685 2609   
4341 STATE ST. RD. P.O. BOX 220   SE DECISION MADE: 03-JUL-13
SKANEATELES FALLS NY 13153 0220   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)
BIOMET, INC.                      510(k) NO: K131670(TRADITIONAL)
ATTN: SUZANA  OTANO               PHONE NO : 305 269 6386   
56 EAST BELL DR. P.O. BOX 587     SE DECISION MADE: 03-JUL-13
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX DISTAL RADIUS PLATE SYSTEM
ARTHREX, INC.                     510(k) NO: K131474(TRADITIONAL)
ATTN: COURTNEY  SMITH             PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 03-JUL-13
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER
AIRSTRIP TECHNOLOGIES, LP         510(k) NO: K131786(TRADITIONAL)
ATTN: ROBERT  ANDREW MILLER       PHONE NO : 210 363 8753   
335 E. SONTERRA BLVD. SUITE 200   SE DECISION MADE: 03-JUL-13
SAN ANTONIO TX 78258              510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: ETII SA FIXTURE SYSTEM
HIOSSEN INC.                      510(k) NO: K123471(TRADITIONAL)
ATTN: PATRICK  LIM                PHONE NO : 888 679 0001   
85 BEN FAIRLESS DRIVE             SE DECISION MADE: 05-JUL-13
FAIRLESS HILLS PA 19030           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS
SPS MEDICAL SUPPLY CORP.          510(k) NO: K130211(SPECIAL)
ATTN: MICHAEL G NOLAN             PHONE NO : 585 359 0130   
6789 WEST HENRIETTA RD.           SE DECISION MADE: 05-JUL-13
RUSH NY 14543                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSCORP ACIF SYSTEM
TRANSCORP, INC.                   510(k) NO: K121178(SPECIAL)
ATTN: ANDREW  RODENHOUSE          PHONE NO : 616 855 5375   
1000 100TH ST. SW, SUITE F        SE DECISION MADE: 05-JUL-13
BYRON CENTER MI 49315             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISUS IMPLANT SUPRASTRUCTURES
DENTSPLY INTERNATIONAL, INC.      510(k) NO: K122424(TRADITIONAL)
ATTN: HELEN  LEWIS                PHONE NO : 717 845 4229   
SUSQUEHANNA COMMERCE CTR., 221 W. SE DECISION MADE: 05-JUL-13
YORK PA 17404                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K131283(TRADITIONAL)
ATTN: DANIELLE  MUELLER           PHONE NO : 901 290 5904   
5677 AIRLINE RD.                  SE DECISION MADE: 05-JUL-13
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ERMIS STERILIZATION CONTAINER SYSTEM
ERMIS MEDIZINTECHNIK              510(k) NO: K123234(TRADITIONAL)
ATTN: ANDRE  WEINGERL             PHONE NO : 497 463995 40
GRIESWEG 47                       SE DECISION MADE: 05-JUL-13
MUEHLHEIM, BADEN-WUERTTEMBERG    G510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
HARTALEGA SDN BHD                 510(k) NO: K130473(TRADITIONAL)
ATTN: NURUL AISYAH  KONG BT ABDULLPHONE NO : 603 327102 77
NO. 7, KAWASAN PERUSAHAAN SURIA   SE DECISION MADE: 05-JUL-13
BESTARI JAYA    MY 45600          510(k) STATEMENT

DEVICE: TIBURON SURGICAL DRAPE
CARDINAL HEALTH 200, LLC          510(k) NO: K130404(TRADITIONAL)
ATTN: LAVENIA  FORD               PHONE NO : 847 887 3323   
1430 WAUKEGAN ROAD                SE DECISION MADE: 05-JUL-13
WAUKEGAN IL 60085                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
STERIS CORPORATION                510(k) NO: K131078(SPECIAL)
ATTN: MARCIA L BENEDICT           PHONE NO : 440 392 7063   
5960 HEISLEY                      SE DECISION MADE: 05-JUL-13
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLICKFINE AUTOPROTECT PEN NEEDLE
YPSOMED AG                        510(k) NO: K131123(TRADITIONAL)
ATTN: BENJAMIN  REINMANN          PHONE NO : 004 1344 244117
BRUNNMATTSTRASSE 6                SE DECISION MADE: 05-JUL-13
BURGDORF    SZ CH-3401            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLICKFINE PEN NEEDLE
YPSOMED AG                        510(k) NO: K131125(TRADITIONAL)
ATTN: BENJAMIN  REINMANN          PHONE NO : 004 1344 243117
BRUNNMATTSTRASSE 6                SE DECISION MADE: 05-JUL-13
BURGDORF    SZ CH-3401            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR
CHANGZHOU SINOLINKS MEDICAL INNOVA510(k) NO: K131511(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 212281 5850
P.O. BOX 120-119                  SE DECISION MADE: 05-JUL-13
SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUICK VUE INFLUENZA
QUIDEL CORPORATION                510(k) NO: K131599(SPECIAL)
ATTN: JOHN D TAMERIUS, PH.D.      PHONE NO : 858 552 7908   
10165 MCKELLAR COURT              SE DECISION MADE: 05-JUL-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MECTALIF
MEDACTA INTERNATIONAL             510(k) NO: K131671(SPECIAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 322 3289   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 05-JUL-13
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
MAQUET CARDIOPULMONARY AG         510(k) NO: K131666(SPECIAL)
ATTN: SARAH  BETZ                 PHONE NO : 011 497478 9210
NEUE ROTTENBURGER STR. 37         SE DECISION MADE: 05-JUL-13
HECHINGEN    GM 72379             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOFIA INFLUENZA A+B FIA
QUIDEL CORP.                      510(k) NO: K131606(SPECIAL)
ATTN: JOHN D TAMERIUS, PH.D.      PHONE NO : 858 552 7908   
10165 MCKELLAR CT.                SE DECISION MADE: 05-JUL-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SFI BAR ABUTMENTS
STERNGOLD DENTAL LLC              510(k) NO: K130183(ABBREVIATED)
ATTN: MARIA  RAO                  PHONE NO : 508 226 5660   
23 Frank Mossberg Drive           SE DECISION MADE: 07-JUL-13
Attleboro MA 02703                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMBIO REMOTE HEALTH MONITORING SYSTEM
ARRAYENT HEALTH LLC D/B/A AMBIO HE510(k) NO: K130676(TRADITIONAL)
ATTN: KEVIN  JONES                PHONE NO : 973 568 0323   
1266 EAST MAIN STREET SUITE 700R  SE DECISION MADE: 08-JUL-13
STAMFORD CT 06902                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WRIST AUTOMATIC BLOOD PRESSURE MONITOR
HONSUN (NANTONG) CO., LTD         510(k) NO: K131463(TRADITIONAL)
ATTN: SELINA  QIAN                PHONE NO : 86 0513 80580022
ADD: NO8 TONGXING ROAD            SE DECISION MADE: 08-JUL-13
JIANGSU    CH 226009              510(k) STATEMENT

DEVICE: NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS
NEXUS MEDICAL, LLC                510(k) NO: K130879(TRADITIONAL)
ATTN: HEATHER  TURNER             PHONE NO : 913 451 2234   
11315 STRANG LINE ROAD            SE DECISION MADE: 09-JUL-13
LENEXA KS 66215                   510(k) STATEMENT

DEVICE: STATSEAL DISC
BIOLIFE, LLC                      510(k) NO: K130324(TRADITIONAL)
ATTN: CLAUDIA  MASSELINK          PHONE NO : 941 360 1300   
9163 25TH COURT EAST              SE DECISION MADE: 09-JUL-13
SARASOTA FL 34243                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC
COLOPLAST A/S                     510(k) NO: K131072(TRADITIONAL)
ATTN: BRIAN  SCHMIDT              PHONE NO : 612 302 4987   
1601 WEST RIVER ROAD N            SE DECISION MADE: 09-JUL-13
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DLP CORONARY OSTIAL PERFUSION CANNULAE
MEDTRONIC, INC.                   510(k) NO: K131269(SPECIAL)
ATTN: KEVIN T LAM                 PHONE NO : 763 526 2360   
7611 NORTHLAND DRIVE              SE DECISION MADE: 10-JUL-13
MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUSEFORCE IMPLANT SYSTEM
SOLANA SURGICAL, LLC              510(k) NO: K124045(TRADITIONAL)
ATTN: JOE  CLIFT                  PHONE NO : 901 818 1860   
6363 POPLAR AVENUE SUITE 312      SE DECISION MADE: 10-JUL-13
MEMPHIS TN 38119                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DERMA HOOD
GLOBALMEDIA GROUP, LLC            510(k) NO: K131338(TRADITIONAL)
ATTN: NICHOLAS  CAMPBELL          PHONE NO : 480 922 0044   
15020 N. 74TH ST.                 SE DECISION MADE: 10-JUL-13
SCOTTSDALE AZ 85260               510(k) STATEMENT

DEVICE: EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT
BOSTON SCIENTIFIC CORP.           510(k) NO: K130391(TRADITIONAL)
ATTN: VICKY L HAGENS              PHONE NO : 763 255 0303   
TWO SCIMED PLACE                  SE DECISION MADE: 10-JUL-13
MAPLE GROVE MN 55311 1566         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QDC-PRO, AND NOX-RIP
NOX MEDICAL                       510(k) NO: K124062(TRADITIONAL)
ATTN: KOLBRUN E OTTOSDOTTIR       PHONE NO : 354 570717 0
VATNAGORDUM 18                    SE DECISION MADE: 10-JUL-13
REYKJAVIK    IC 104               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIGIS RX N MEDIUM; AIGIS RX N LARGE
TYRX ,INC                         510(k) NO: K131007(TRADITIONAL)
ATTN: SUSAN  OLINGER              PHONE NO : 732 964 1110   
1 DEER PARK DRIVE SUITE G         SE DECISION MADE: 10-JUL-13
MONMOUTH JUNCTION NJ 08852        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H
PHADIA AB                         510(k) NO: K131738(SPECIAL)
ATTN: CARINA  MAGNUSSON           PHONE NO : 46 18 165000
RAPSGATAN 7 P.O. BOX 6460         SE DECISION MADE: 10-JUL-13
UPPSALA    SW SE - 75137          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)
BSN MEDICAL, INC.                 510(k) NO: K131496(SPECIAL)
ATTN: CARROLL D HOYLE             PHONE NO : 828 879 5100   
100 BEIERSDORF DRIVE              SE DECISION MADE: 10-JUL-13
RUTHERFORD COLLEGE NC 28671       510(k) STATEMENT

DEVICE: STIMEL-03
STIMEL LTD                        510(k) NO: K130424(TRADITIONAL)
ATTN: RAYMOND J KELLY IV          PHONE NO : 203 880 4091   
57 LAZY BROOK ROAD                SE DECISION MADE: 11-JUL-13
MONROE CT 06468                   510(k) STATEMENT

DEVICE: NXSTAGE DOSING CALCULATOR
NXSTAGE MEDICAL, INC.             510(k) NO: K130460(TRADITIONAL)
ATTN: NNAMDI  NWACHUKWU           PHONE NO : 978 332 8477   
350 Merrimack St                  SE DECISION MADE: 11-JUL-13
LAWRENCE MA 01843                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONTERIS MEDICAL NEUROBLATE SYSTEM
MONTERIS MEDICAL, INC.            510(k) NO: K131278(TRADITIONAL)
ATTN: CRAIG  COOMBS               PHONE NO : 510 337 0140   
1193 SHERMAN ST                   SE DECISION MADE: 11-JUL-13
ALAMEDA CA 94501                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXUS HEMORRHOID LIGATOR
INX MEDICAL                       510(k) NO: K131282(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
1819 CLARKSON ROAD SUITE 206      SE DECISION MADE: 11-JUL-13
CHESTERFIELD MO 63017             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEARTSINE SAMARITAN PAD 350P
HEARTSINE TECHNOLOGIES, INC.      510(k) NO: K123881(TRADITIONAL)
ATTN: JAMES  MCGUINNESS           PHONE NO : 442 890939 419
203 AIRPORT ROAD WEST BELFAST     SE DECISION MADE: 11-JUL-13
NORTHERN    EI BT3 9ED            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ETCH GEL
DMG AMERICA, LLC                  510(k) NO: K131248(TRADITIONAL)
ATTN: PAMELA  PAPINEUA, RAC       PHONE NO : 978 772 3552   
5 WHITCOMB AVENUE                 SE DECISION MADE: 11-JUL-13
AYER MA 01432                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE
SILVERBAY LLC, D/B/A QUASAR BIO-TE510(k) NO: K130225(TRADITIONAL)
ATTN: ROBERT  WAGNER              PHONE NO : 865 982 5552   
2424DEMPSTER DRIVE                SE DECISION MADE: 11-JUL-13
CORALVILLE IA 52241               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MESOTHELIUM DENTAL MEMBRANE
KENSEY NASH CORPORATION           510(k) NO: K121310(TRADITIONAL)
ATTN: LORI  BURNS, MS, RAC        PHONE NO : 484 713 2100   
735 PENNSYLVANIA DRIVE            SE DECISION MADE: 11-JUL-13
EXTON PA 19341                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLINICAL ALERT NOTIFICATION
EXTENSION , INC                   510(k) NO: K130339(TRADITIONAL)
ATTN: TIM  GEE                    PHONE NO : 503 481 2370   
7250 SW 154TH TERRACE             SE DECISION MADE: 11-JUL-13
BEAVERTON OR 97007                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E
WELL-LIFE HEALTHCARE LIMITED      510(k) NO: K123075(ABBREVIATED)
ATTN: CHIN-CHIH  HSIEH            PHONE NO : 886 2 29282112
1FL, NO.16, LANE 454 JUNGJENG RD. SE DECISION MADE: 11-JUL-13
YUNGHE CITY, TAIPEI COUNTY    TW C510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXUS ANTERIOR CERVICAL PLATE SYSTEM
CORE-NEXUS                        510(k) NO: K131520(SPECIAL)
ATTN: LISA  PETERSON              PHONE NO : 512 507 0746   
14001 HUNTERS PASS                SE DECISION MADE: 11-JUL-13
AUSTIN TX 78734                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGITRON 4.0 DUAL RF S5-IEC
ELLMAN INTERNATIONAL, INC.        510(k) NO: K123366(TRADITIONAL)
ATTN: ALISON  SATHE               PHONE NO : 513 658 8960   
3333 ROYAL AVENUE                 SE DECISION MADE: 12-JUL-13
OCEANSIDE NY 11572                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FACET FIXX
NEXXT SPINE LLC                   510(k) NO: K131417(TRADITIONAL)
ATTN: KAREN E WARDEN PHD          PHONE NO : 440 729 8457   
8202 SHERMAN ROAD                 SE DECISION MADE: 12-JUL-13
CHESTERLAND OH 44026 2141         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: YAMAHACHI DENTURE BASE RESINS
YAMAHACHI DENTAL MANUFACTURING CO.510(k) NO: K131036(TRADITIONAL)
ATTN: CLAUDE  BERTHOIN            PHONE NO : 386 672 0450   
110 EASTGRANADA BLVD. SUITE 209   SE DECISION MADE: 12-JUL-13
ORMOND BEACH FL 32176             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLEA
CONVERGENT DENTAL, INC            510(k) NO: K130420(TRADITIONAL)
ATTN: CARRIE  HETRICK             PHONE NO : 512 327 9997   
611 WEST 5TH STREET THIRD FLOOR   SE DECISION MADE: 12-JUL-13
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPULSE HAIR REMOVAL SYSTEM
CYDEN LIMITED                     510(k) NO: K130315(TRADITIONAL)
ATTN: DAVID  BRODERICK            PHONE NO : 44 1792 485755
TECHNIUM 2, KINGS ROAD            SE DECISION MADE: 12-JUL-13
SWANSEA, WEST GLAMORGAN    UK SA1 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIPLATFORM MEDICAL IMAGING SUITE
HINACOM SOFTWARE AND TECHNOLOGY, L510(k) NO: K131424(TRADITIONAL)
ATTN: YI  ISABELLE SUN            PHONE NO : 86 10 62701653
SUITE B301, R&D PLAZA, TSINGHUA SCSE DECISION MADE: 12-JUL-13
BEIJING    CH 100084              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PADSCAN HD SERIES BLADDER SCANNER
CARENOSO TECHNOLOGY CO., LTD.     510(k) NO: K131227(TRADITIONAL)
ATTN: ZHANG  WENSHENG             PHONE NO : 86 415 6123779
4TH FL, NO. 11 BLDG INITIATING ZONSE DECISION MADE: 12-JUL-13
DANDONG,  LIAONING    CH 118009   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: INGENUITY DIGITAL PET/CT
PHILIPS HEALTHCARE (CLEVELAND)    510(k) NO: K123599(TRADITIONAL)
ATTN: MICHAEL S PRETO             PHONE NO : 440 483 2295   
595 MINER RD.                     SE DECISION MADE: 12-JUL-13
CLEVELAND OH 44143                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K130806(SPECIAL)
ATTN: CHRISTINE  VERGELY          PHONE NO : 805 866 6999   
2225 SPERRY AVE, SUITE 1000       SE DECISION MADE: 12-JUL-13
VENTURA CA 93003                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHARPSTANK REUSABLE SHARPS CONTAINER
REHRIG PACIFIC COMPANY            510(k) NO: K131087(ABBREVIATED)
ATTN: DAVID  OLMSTEAD             PHONE NO : 615 210 4698   
614 HUNTERS LANE                  SE DECISION MADE: 12-JUL-13
BRENTWOOD TN 37027                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REMEL XPECT FLU A&B
REMEL, INC.                       510(k) NO: K131804(SPECIAL)
ATTN: CINDY  KNAPP                PHONE NO : 800 871 8909   
12076 Santa Fe Dr                 SE DECISION MADE: 12-JUL-13
LENEXA KS 66215                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)
ROTATION MEDICAL, INC.            510(k) NO: K131637(TRADITIONAL)
ATTN: GAIL  SCHROEDER             PHONE NO : 763 746 7521   
15350 25TH AVENUE N SUITE 100     SE DECISION MADE: 12-JUL-13
PLYMOUTH MN 55447                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
GE VINGMED ULTRASOUND AS          510(k) NO: K131514(SPECIAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 W INNOVATION DR., RP-2138    SE DECISION MADE: 12-JUL-13
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LANX FUSION SYSTEM
LANX, INC.                        510(k) NO: K131547(SPECIAL)
ATTN: ALAN  BURKHOLDER            PHONE NO : 303 442 7500   
310 INTERLOCKEN PARKWAY SUITE 120 SE DECISION MADE: 12-JUL-13
BROOMFIELD CO 80021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 611 ANKLE FUSION NAIL
TORNIER SAS                       510(k) NO: K130051(TRADITIONAL)
ATTN: DAMIEN  GUILLAUD            PHONE NO : 003 347 6613500
161 RUE LAVOISIER                 SE DECISION MADE: 15-JUL-13
MONTBONNOT CEDEX    FR 38334      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DENTEK EASY BRUSH WITH FLUORIDE
DENTEK ORAL CARE, INC.            510(k) NO: K130186(TRADITIONAL)
ATTN: LINDA  GILES                PHONE NO : 865 983 1300   
307 EXCELLENCE WAY                SE DECISION MADE: 15-JUL-13
MARYVILLE TN 37801                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEOTIS; NEOTIS 50
SBM SCIENCES FOR BIO MATERIALS    510(k) NO: K130953(SPECIAL)
ATTN: DENIS  CLEMENT              PHONE NO : 33 562422 101
ZI DU MONGE                       SE DECISION MADE: 15-JUL-13
LOURDES    FR 65100               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTAVIPRO STERICAN 30G
B. BRAUN MELSUNGEN AG             510(k) NO: K131040(TRADITIONAL)
ATTN: KARIN  LUBBERS              PHONE NO : 49 617276 464886
BAHNSTRASSE 42-46                 SE DECISION MADE: 15-JUL-13
FRIEDRICHSDORF, HESSE    GM 61381 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
VATECH CO., LTD.                  510(k) NO: K130585(TRADITIONAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 15-JUL-13
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION
BECKMAN COULTER, INC.             510(k) NO: K130253(TRADITIONAL)
ATTN: NANCY  NADLER               PHONE NO : 305 380 4191   
11800 SW 147 AVE                  SE DECISION MADE: 15-JUL-13
MIAMI FL 33196 2500               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE
ALL MEDICUS CO., LTD              510(k) NO: K130657(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
1515 E. KATELLA AVE. UNIT 2115    SE DECISION MADE: 15-JUL-13
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL
INVIVO CORPORATION                510(k) NO: K131382(SPECIAL)
ATTN: RUSTY  KELLY                PHONE NO : 407 455 6166   
12151 RESEARCH PKWY               SE DECISION MADE: 15-JUL-13
ORLANDO FL 32826                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION
CONSTANT CARE, LLC                510(k) NO: K130360(TRADITIONAL)
ATTN: SETH A MAILHOT              PHONE NO : 202 469 4980   
1300 I ST, NW, 11TH FLOOR EAST    SE DECISION MADE: 15-JUL-13
WASHINGTON DC 20005 3314          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUSCOPE SERIES PATIENT MONITOR
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K131763(SPECIAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 120-119                  SE DECISION MADE: 15-JUL-13
SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RADVISION
ACOUSTIC MEDSYSTEMS, INC.         510(k) NO: K131428(TRADITIONAL)
ATTN: JENNIFER  WILLIAMS          PHONE NO : 217 239 0900   
208 BURWASH AVE.                  SE DECISION MADE: 16-JUL-13
SAVOY IL 61874                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXPORT ADVANCE ASPIRATION CATHETER
MEDTRONIC INC.                    510(k) NO: K130536(TRADITIONAL)
ATTN: COLLEEN  MULLINS            PHONE NO : 978 739 3267   
37A CHERRY HILL DRIVE             SE DECISION MADE: 16-JUL-13
DANVERS MA 01923                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LPP (LOW PROFILE PORT)
PFM MEDICAL, INC                  510(k) NO: K122402(TRADITIONAL)
ATTN: SALVADORE  PALOMARES, RAC   PHONE NO : 760 758 8749   
1815 ASTON AVE, SUITE 106         SE DECISION MADE: 16-JUL-13
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HERMES MEDICAL IMAGING SUITE V5.3
HERMES MEDICAL SOLUTIONS, AB      510(k) NO: K131233(TRADITIONAL)
ATTN: JOAKIM  ARWIDSON            PHONE NO : 46 819032 5
SKEPPSBRON 44                     SE DECISION MADE: 16-JUL-13
STOCKHOLM    SW 111 30            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD PEN NEEDLE
BECTON DICKINSON & CO.            510(k) NO: K131358(TRADITIONAL)
ATTN: PASQUALE  AMATO             PHONE NO : 201 847 4513   
1 BECTON DRIVE MC 372             SE DECISION MADE: 16-JUL-13
FRANKLIN LAKES NJ 07417 1885      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
STERIS CORPORATION                510(k) NO: K131120(TRADITIONAL)
ATTN: BILL  BRODBECK              PHONE NO : 440 392 7690   
5960 HEISLEY ROAD                 SE DECISION MADE: 16-JUL-13
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
VISIONSENSE, LTD.                 510(k) NO: K131434(SPECIAL)
ATTN: GERARD J PRUD'HOMME         PHONE NO : 202 637 5735   
555 13TH STREET, NW               SE DECISION MADE: 16-JUL-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIVERSAL OPAQUE
SHOFU DENTAL CORPORATION          510(k) NO: K131504(TRADITIONAL)
ATTN: DAVID P MORAIS              PHONE NO : 760 736 3277   
1225 STONE DRIVE                  SE DECISION MADE: 16-JUL-13
SAN MARCOS CA 92078               510(k) STATEMENT

DEVICE: DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE
DEMETECH CORP.                    510(k) NO: K130083(TRADITIONAL)
ATTN: ANTHONY J DIMERCURIO        PHONE NO : 305 824 1048   
14175 NW 60th Ave                 SE DECISION MADE: 17-JUL-13
Miami Lakes FL 33014              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFE SPINE PLATEAU SPACER SYSTEM
LIFE SPINE                        510(k) NO: K131077(TRADITIONAL)
ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   
2401 W. HASSELL RD. SUITE 1535    SE DECISION MADE: 17-JUL-13
HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOFLIP CATHETER
CROSPON, LTD.                     510(k) NO: K130906(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 17-JUL-13
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
COOK, INC.                        510(k) NO: K130766(SPECIAL)
ATTN: DAVID  LEHR                 PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 17-JUL-13
Blmgtn IN 47404                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER
MENTOR WORLDWIDE LLC              510(k) NO: K131853(SPECIAL)
ATTN: MANCHI  CHEUNG              PHONE NO : 805 879 6790   
201 MENTOR DRIVE                  SE DECISION MADE: 17-JUL-13
SANTA BARBARA CA 93111            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GREENCROSS SURGICAL MASK
JINGZHOU HAIXIN GREEN CROSS MEDICA510(k) NO: K123787(TRADITIONAL)
ATTN: XIANGYANG  SONG             PHONE NO : 312 479 0030   
6 VANDERBLET ROAD                 SE DECISION MADE: 17-JUL-13
ACTON MA 01720                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VALUTRODE NEUROSTIMLATION ELECTRODES
AXELGAARD MFG. CO., LTD.          510(k) NO: K130987(TRADITIONAL)
ATTN: DAN P JEFFERY               PHONE NO : 760 451 8000   
520 INDUSTRIAL WAY                SE DECISION MADE: 17-JUL-13
FALLBROOK CA 92028 2244           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COBAS C BILIRUBIN TOTAL GEN.3
ROCHE DIAGNOSTICS                 510(k) NO: K131544(TRADITIONAL)
ATTN: LISA K KLINEDINST           PHONE NO : 317 521 1942   
9115 SOUTH HAGUE ROAD             SE DECISION MADE: 17-JUL-13
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACRYLIC HERBST APPLIANCE
GERGENS ORTHODONTIC LAB           510(k) NO: K113126(TRADITIONAL)
ATTN: KAREN E WARDEN, PHD         PHONE NO : 623 879 6066   
11825 State Route 40 Ste 101      SE DECISION MADE: 17-JUL-13
Dunlap IL 61525                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR
THORATEC CORP                     510(k) NO: K131179(SPECIAL)
ATTN: YVERRE  BOBAY               PHONE NO : 781 852 8276   
23 4th Ave                        SE DECISION MADE: 18-JUL-13
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
CONFORMIS, INC.                   510(k) NO: K131467(TRADITIONAL)
ATTN: AMITA  SHAH                 PHONE NO : 781 345 9164   
28 Crosby Dr                      SE DECISION MADE: 18-JUL-13
Bedford MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ICT
IMRIS, INC.                       510(k) NO: K130224(TRADITIONAL)
ATTN: DANIEL  BIANK               PHONE NO : 952 358704 6
100-1370 SONY PLACE               SE DECISION MADE: 18-JUL-13
WINNIPEG, MB    CA R3T 1N5        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
BIO COMPRESSION SYSTEMS, INC.     510(k) NO: K131327(TRADITIONAL)
ATTN: MAUREEN  GARNER             PHONE NO : 732 779 7422   
1983 HAZELWOOD ROAD               SE DECISION MADE: 18-JUL-13
TOMS RIVER NJ 08753               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERTUS 140 CERTUSURGGT SURGICAL TOOL
NEUWAVE MEDICAL, INC.             510(k) NO: K130399(TRADITIONAL)
ATTN: DAN  KOSEDNAR               PHONE NO : 608 512 1592   
3529 Anderson St                  SE DECISION MADE: 18-JUL-13
Madison WI 53704                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF)
VENOUS HEALTH SYSTEMS, INC.       510(k) NO: K131046(TRADITIONAL)
ATTN: RICH  LAGUNA                PHONE NO : 650 646 3327   
3270 Alpine Rd                    SE DECISION MADE: 18-JUL-13
Portola Valley CA 94028           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAOMI-CT
LK CONSULTING GROUP               510(k) NO: K123332(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
1515 E KATELLA AVE. UNIT 2115     SE DECISION MADE: 18-JUL-13
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM
GENORAY CO., LTD.                 510(k) NO: K130088(TRADITIONAL)
ATTN: JAE  KIM                    PHONE NO : 855 436 6729   
1073 N, BATAVIA ST                SE DECISION MADE: 18-JUL-13
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
NEOSURGICAL LTD                   510(k) NO: K131688(SPECIAL)
ATTN: ORLA  BRENNAN               PHONE NO : 353 914210 00
BLOCK 12 GALWAY TECHNOLOGY PARK, PSE DECISION MADE: 18-JUL-13
GALWAY    EI EI                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLID GEL PAD
BLUEMTECH                         510(k) NO: K131905(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
1515 E KATELLA AVE UNIT 2115      SE DECISION MADE: 18-JUL-13
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
RANDOX LABORATORIES, LTD.         510(k) NO: K131776(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 028 944224 13
55 DIAMOND RD.                    SE DECISION MADE: 18-JUL-13
CRUMLIN, COUNTY ANTRIM    UK BT29 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INPULSE LASER
INCISIVE INC.                     510(k) NO: K131805(SPECIAL)
ATTN: KATHY  MAYNOR               PHONE NO : 352 586 3113   
26 REBECCA CT                     SE DECISION MADE: 18-JUL-13
HOMOSASSA FL 34446                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)
JVC KENWOOD CORPORATION           510(k) NO: K131137(TRADITIONAL)
ATTN: TSUKASA  TASHIRO            PHONE NO : 81 258246 611
300-OYA UEDA-SHI                  SE DECISION MADE: 18-JUL-13
NAGANO-KEN    JA 386-0192         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER
CARDIOSOLUTIONS INC               510(k) NO: K131332(SPECIAL)
ATTN: MICHELE  LUCE               PHONE NO : 781 344 0801   
375 WEST STREET                   SE DECISION MADE: 19-JUL-13
MASSACHUSETTS MA 02379            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KLOCKNER DENTAL IMPLANT ABUTMENTS
SOADCO, S.L.                      510(k) NO: K122988(ABBREVIATED)
ATTN: MARIA  MITJANETA            PHONE NO : 376 80 0599
AV FITER I ROSSELL 4 BIS LOCAL 2  SE DECISION MADE: 19-JUL-13
ESCALDES-ENGORDANY    AN AD-700   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IHEALTH CLOUD
ANDON HEALTH CO., LTD             510(k) NO: K131203(TRADITIONAL)
ATTN: YI  LIU                     PHONE NO : 86 22 60526161
NO. 3 JINPING ROAD,YA' AN STREET  SE DECISION MADE: 19-JUL-13
TIANJIN    CH 300193              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
TECHNOMED EUROPE                  510(k) NO: K130136(TRADITIONAL)
ATTN: PIERRE  VREULS              PHONE NO : 31 43 4086868
AMERIKALAAN 71                    SE DECISION MADE: 19-JUL-13
MAASTRICHT AIRPORT    NL 6199 AE  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)
ESSEX INDUSTRIES, INC. D/B/A ESSEX510(k) NO: K130068(TRADITIONAL)
ATTN: KEN  SEISE                  PHONE NO : 314 338 8533   
8007 CHIVVIS DRIVE                SE DECISION MADE: 19-JUL-13
ST. LOUIS MO 63123 2395           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER
REFLECTANCE MEDICAL INC           510(k) NO: K130079(TRADITIONAL)
ATTN: NANDINI  MURTHY             PHONE NO : 781 710 5378   
116 FLAUNDERS ROAD, SUITE 1000    SE DECISION MADE: 19-JUL-13
WESTBOROUGH MA 01581              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELIXBO PM545
XBO MEDICAL SYSTEMS CO., LTD      510(k) NO: K130658(TRADITIONAL)
ATTN: JINHONG  GUO                PHONE NO : 86 316 2596056
INDUSTRIAL PK, RARE EARTH HI-TECH SE DECISION MADE: 19-JUL-13
MONGOLIA    CH 014030             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TRANSCEND
SYNERON MEDICAL LTD.              510(k) NO: K120510(TRADITIONAL)
ATTN: SAM  WADE                   PHONE NO : 972 543 303402
INDUSTRIAL ZONE, TAVOR BUILDING, PSE DECISION MADE: 19-JUL-13
YOKNEAM ILLIT    IS 20692         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIGATION PIN
EVERGREEN ORTHOPEDIC RESEARCH LAB 510(k) NO: K131130(TRADITIONAL)
ATTN: JEFF  STEPHANIAN            PHONE NO : 425 284 7262   
11321 NE 120TH ST                 SE DECISION MADE: 19-JUL-13
KIRKLAND WA 98034                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW
STABILIZ ORTHOPAEDICS, LLC        510(k) NO: K130731(TRADITIONAL)
ATTN: DOUGLAS L CERYNIK, MD       PHONE NO : 610 458 8555   
665 STOCKTON DRIVE                SE DECISION MADE: 19-JUL-13
EXTON PA 19341                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: T1040 AKA AURAWAVE
ENDURANCE THERAPEUTICS            510(k) NO: K124055(TRADITIONAL)
ATTN: BRAD  BREZDEN               PHONE NO : 866 854 2342   
122B - FIRST STREET NE            SE DECISION MADE: 19-JUL-13
DAUPHIN, MANITOBA    CA R7N 1B5   510(k) STATEMENT

DEVICE: IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE
BIO COMPRESSION SYSTEMS, INC.     510(k) NO: K131306(TRADITIONAL)
ATTN: MAUREEN  GARNER             PHONE NO : 732 779 7422   
1983 HAZELWOOD ROAD               SE DECISION MADE: 22-JUL-13
TOMS RIVER NJ 08753               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K131191(TRADITIONAL)
ATTN: SUSAN  KAGAN                PHONE NO : 508 880 8097   
325 PARAMOUNT DR.                 SE DECISION MADE: 22-JUL-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RHYTHMIA MAPPING SYSTEM
RHYTHMIA MEDICAL, INC             510(k) NO: K130750(TRADITIONAL)
ATTN: LEON  AMARIGLIO             PHONE NO : 617 591 9191   
111 SOUTH BEDFORD ST SUITE 205    SE DECISION MADE: 22-JUL-13
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MR CONDITIONAL PRESSON ELECTRODE
RHYTHMLINK INTERNATIONAL, LLC     510(k) NO: K130220(TRADITIONAL)
ATTN: JAMES M MEWBORNE            PHONE NO : 803 252 1222   
1140 FIRST STREET SOUTH           SE DECISION MADE: 22-JUL-13
COLUMBIA SC 29209                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICRO AMBULATORY ECG RECORDER
DIMETEK DIGITAL MEDICAL TECHNOLOGI510(k) NO: K131572(TRADITIONAL)
ATTN: JIMMY  GUAN                 PHONE NO : 86 755 88855978
3/F-A2, UNIT 8, XING HUA BUILDING,SE DECISION MADE: 22-JUL-13
SHEKOU, SHENZHEN    CH            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SORIN "CONNECT DATA MANAGEMENT SYSTEM"
SORIN GROUP DEUTSCHLAND GMBH      510(k) NO: K131816(TRADITIONAL)
ATTN: RENATE  GOEBERT             PHONE NO : 498 89 323010
LINDBERGH STRASSE 25              SE DECISION MADE: 23-JUL-13
MUNCHEN    GM 80939               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM
DENTSPLY INTL., INC.              510(k) NO: K130862(TRADITIONAL)
ATTN: HELEN  LEWIS                PHONE NO : 717 849 4229   
221 WEST PHILADELPHIA STREET SUITESE DECISION MADE: 23-JUL-13
YORK PA 17404                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHARPSCAN
MEDICAL ENGINEERING DEVELOPMENT SO510(k) NO: K123807(TRADITIONAL)
ATTN: TIM  CORESSEL               PHONE NO : 303 452 0484   
11060 IRMA DRIVE                  SE DECISION MADE: 23-JUL-13
NORTHGLENN CO 80233               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRAG-LOC SYSTEM
ACUMED LLC                        510(k) NO: K130986(TRADITIONAL)
ATTN: KARA  BUDOR                 PHONE NO : 503 207 1412   
5885 NW CORNELIUS PASS RD.        SE DECISION MADE: 23-JUL-13
HILLSBORO OR 97124 9432           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORUM GLAUCOMA WORKPLACE
CARL ZEISS MEDITEC AG             510(k) NO: K130648(TRADITIONAL)
ATTN: MANDY  AMBRECHT             PHONE NO : 925 557 4561   
5160 HACIENDA DRIVE               SE DECISION MADE: 23-JUL-13
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIGHTINGALE MONITORING SYSTEM
ZOE MEDICAL, INC.                 510(k) NO: K130740(TRADITIONAL)
ATTN: JAMES  CHICKERING           PHONE NO : 978 887 1410   
460 BOSTON ST.                    SE DECISION MADE: 23-JUL-13
TOPSFIELD MA 01983 1223           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPACELABS HEALTHCARE CARDIOEXPRESS
SPACELABS HEALTHCARE LTD.         510(k) NO: K130207(TRADITIONAL)
ATTN: THOMAS  KROENKE             PHONE NO : 303 956 4232   
PO BOX 3018                       SE DECISION MADE: 23-JUL-13
NEDERLAND CO 80466                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRSONETT AIR-4
AIRSONETT, AB                     510(k) NO: K130702(TRADITIONAL)
ATTN: CONSTANCE G BUNDY           PHONE NO : 763 574 1976   
435 RICE CREEK TERRACE NE         SE DECISION MADE: 23-JUL-13
FRIDLEY MN 55432                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRAEXTEND USWS-900A V2.1 AND V3.1
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K131822(TRADITIONAL)
ATTN:                             PHONE NO : 
2441 MICHELLE DR.                 SE DECISION MADE: 23-JUL-13
TUSTIN CA 92780 2068              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MFP-051
GC AMERICA, INC.                  510(k) NO: K123631(TRADITIONAL)
ATTN: MARK  HEISS                 PHONE NO : 708 597 0900   
3737 WEST 127TH ST.               SE DECISION MADE: 23-JUL-13
ALSIP IL 60803                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESIE APPS SUITE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132062(TRADITIONAL)
ATTN: PATRICK J LYNCH             PHONE NO : 650 694 5658   
685 EAST MIDDLEFIELD ROAD         SE DECISION MADE: 23-JUL-13
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MTA CEMENTS
S&C POLYMER SILICON- UND COMPOSITE510(k) NO: K130125(TRADITIONAL)
ATTN: CHRISTIAN  BOETTCHER        PHONE NO : 49 4121 4830
ROBERT-BOSCH-STRASSE 2            SE DECISION MADE: 24-JUL-13
ELMSHORN, SCHLESWIG-HOLSTEIN    GM510(k) STATEMENT

DEVICE: POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL
PREVENTIVE CARE, INC.             510(k) NO: K130667(TRADITIONAL)
ATTN: ANIL  SEGAT                 PHONE NO : 651 322 9120   
15215 BOULDER TRAIL               SE DECISION MADE: 24-JUL-13
ROSEMOUNT MN 55068                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE
LINA MEDICAL APS                  510(k) NO: K130305(TRADITIONAL)
ATTN: RICHARD  GILLIS             PHONE NO : 512 327 9997   
611 WEST 5TH STRRET THIRD FLOOR   SE DECISION MADE: 24-JUL-13
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EDWARDS EMBOL-X INTRODUCER SHEATH
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K123714(TRADITIONAL)
ATTN: LUKE  MEIDELL               PHONE NO : 801 565 6212   
12050 LONE PEAK PKWY              SE DECISION MADE: 24-JUL-13
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XPERGUIDE
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K131263(ABBREVIATED)
ATTN: JOS V VROONHOVEN            PHONE NO : 310 402794 221
VEENPLUIS 4-6                     SE DECISION MADE: 24-JUL-13
BEST    NL 5684 PC                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAM JUNCTIONAL TOURNIQUET
SAM MEDICAL PRODUCTS              510(k) NO: K131561(TRADITIONAL)
ATTN: JACK N MCCUTCHEON           PHONE NO : 503 639 5474   
27350 SW 95TH AVE STE 3038        SE DECISION MADE: 24-JUL-13
Wilsonville OR 97070              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REFORM PEDICLE SCREW SYSTEM
SPINAL USA                        510(k) NO: K131343(TRADITIONAL)
ATTN: MEREDITH  MAY               PHONE NO : 719 337 7579   
4628 NORTHPARK DRIVE              SE DECISION MADE: 24-JUL-13
COLORADO SPRINGS CO 80918         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMATOLOGY QUALITY CONTROL MIXTURE
R & D SYSTEMS, INC.               510(k) NO: K130962(SPECIAL)
ATTN: AMBREEN  ATHAR              PHONE NO : 612 379 2956   
614 MCKINLEY PL., N.E.            SE DECISION MADE: 24-JUL-13
MINNEAPOLIS MN 55413              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K131690(SPECIAL)
ATTN: YANG  ZHAOHUI               PHONE NO : 86 755 81885640
MINDRAY BUILDING, KEJI 12TH ROAD SSE DECISION MADE: 24-JUL-13
SHENZHEN, GUANGDONG    CH 518057  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC
NOVABAY PHARMACEUTICALS, INC      510(k) NO: K131542(TRADITIONAL)
ATTN: PATSY J TRISLER             PHONE NO : 301 652 5344   
5600 WISCONSIN AVENUE # 509       SE DECISION MADE: 24-JUL-13
CHEVY CHASE MD 20815              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
MEDTRONIC INC.                    510(k) NO: K131964(SPECIAL)
ATTN: LISA  STONE                 PHONE NO : 763 514 9866   
8200 CORAL SEA STREET NE          SE DECISION MADE: 24-JUL-13
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEM-6131
OMRON HEALTHCARE, INC.            510(k) NO: K131742(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 24-JUL-13
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERCUNAV SYSTEM
PHILIPS HEALTHCARE                510(k) NO: K132087(TRADITIONAL)
ATTN: DAVE  SZCZUPAKOWSKI         PHONE NO : 
49 SPADINA AVENUE #310            SE DECISION MADE: 24-JUL-13
TORONTO    CA M5V 2J1             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DUOFLEX COIL SUITE (1.5T)
MR INSTRUMENTS, INC.              510(k) NO: K130706(TRADITIONAL)
ATTN: ROBERT  BECK                PHONE NO : 952 746 1435   
5610 ROWLAND RD. SUITE 145        SE DECISION MADE: 25-JUL-13
MINNEAPOLIS MN 54343              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: HAMMERTOE CORRECTION SYSTEM
ARTHROSURFACE, INC.               510(k) NO: K130859(TRADITIONAL)
ATTN: DAWN J WILSON               PHONE NO : 508 520 3003   
28 FORGE PARKWAY                  SE DECISION MADE: 25-JUL-13
FRANKLIN MA 02038                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTRELIEF
CHATTEM, INC.                     510(k) NO: K131159(TRADITIONAL)
ATTN: ERIC  JOSEPH                PHONE NO : 423 822 3268   
1715 WEST 38TH ST.                SE DECISION MADE: 25-JUL-13
CHATTANOOGA TN 37409              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPRESSYN BAND
DALLEN MEDICAL, INC.              510(k) NO: K130431(TRADITIONAL)
ATTN: AL  MEMMOLO                 PHONE NO : 949 218 0030   
1046 Calle Recodo Ste G           SE DECISION MADE: 25-JUL-13
San Clemente CA 92673             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M-SCAN
BIO-RESEARCH ASSOCIATES, INC.     510(k) NO: K130158(TRADITIONAL)
ATTN: JOHN  RADKE                 PHONE NO : 414 357 7525   
9275 NORTH 49TH STREET SUITE 150  SE DECISION MADE: 25-JUL-13
BROWN DEER WI 53223               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPSTONE(R) SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K123027(TRADITIONAL)
ATTN: LEE  GRANT                  PHONE NO : 901 344 0807   
1800 PYRAMID PLACE                SE DECISION MADE: 25-JUL-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JONES-FX FRACTURE SYSTEM
INSTRATEK, INC.                   510(k) NO: K131620(TRADITIONAL)
ATTN: JEFF  SEAVEY                PHONE NO : 281 890 8020   
4141 Directors Row Ste H          SE DECISION MADE: 25-JUL-13
Houston TX 77092                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K131974(SPECIAL)
ATTN: KRISTINE  CHRISTO           PHONE NO : 508 828 3359   
325 PARAMOUNT DR.                 SE DECISION MADE: 25-JUL-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSIS, SENSIS LITE
SIEMENS MEDICAL SOLUTIONS, INC.   510(k) NO: K131812(SPECIAL)
ATTN: PATRICIA D JONES            PHONE NO : 610 448 3536   
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 25-JUL-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IQQA-LIVER MULTIMODALITY SOFTWARE
EDDA TECHNOLOGY, INC.             510(k) NO: K131498(TRADITIONAL)
ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234 1735   
5 Independence Way                SE DECISION MADE: 25-JUL-13
Princeton NJ 08540                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARRICADE EMBOLIZATION COIL SYSTEM
BLOCKADE MEDICAL                  510(k) NO: K131475(SPECIAL)
ATTN: REBECCA K PINE              PHONE NO : 760 809 5178   
18 Technology Dr Ste 169          SE DECISION MADE: 25-JUL-13
Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARE SU01A SUCTION ASPIRATOR
FOSHAN CARE MEDICAL TECHNOLOGY CO.510(k) NO: K130001(TRADITIONAL)
ATTN: GANG  WU                    PHONE NO : 867 578802 3265
THE 2F AND 3F, G BUILDING, NO.1 HUSE DECISION MADE: 25-JUL-13
FOSHAN, GUANGDONG    CH 528000    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VDRIVE W/V-SONO
STEREOTAXIS, INC.                 510(k) NO: K122659(TRADITIONAL)
ATTN: HORWITZ                     PHONE NO : 
4320 FOREST PARK AVENUE SUITE 100 SE DECISION MADE: 26-JUL-13
ST. LOUIS MO 63108                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM
STERIS CORPORATION                510(k) NO: K123768(TRADITIONAL)
ATTN: MARCIA L BENEDICT           PHONE NO : 440 392 7063   
5960 HEISLEY ROAD                 SE DECISION MADE: 26-JUL-13
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GMK REVISION EXTENSION
MEDACTA INTERNATIONAL             510(k) NO: K123721(TRADITIONAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 437 7085   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 26-JUL-13
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARRX CHANNEL RFA ENDOSCOPIC CATHETER
COVIDIEN LLC                      510(k) NO: K130623(TRADITIONAL)
ATTN: RICHELLE  HOVER             PHONE NO : 408 328 7342   
15 HAMPSHIRE ST                   SE DECISION MADE: 26-JUL-13
MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS
DENTSOLL, INC.                    510(k) NO: K130680(TRADITIONAL)
ATTN: DAVID C FURR                PHONE NO : 512 906 9654   
8708 CAPEHART COVE                SE DECISION MADE: 26-JUL-13
AUSTIN TX 78733                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS
GLOBE MEDICAL, INC.               510(k) NO: K130478(TRADITIONAL)
ATTN: SARAH MARIE  FITZGERALD     PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 26-JUL-13
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DENTAL UNIT WITH CHAIR
XIANYANG NORTH WEST MEDICAL INSTRU510(k) NO: K130410(SPECIAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 237-023                  SE DECISION MADE: 26-JUL-13
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TETRACHROME REAGENTS AND TETRACXP SYSTEM
BECKMAN COULTER, INC.             510(k) NO: K121445(SPECIAL)
ATTN: NANCY  NADLER               PHONE NO : 305 380 4191   
11800 SW 147TH AVE. M/S 31-B06    SE DECISION MADE: 26-JUL-13
MIAMI FL 33196 2500               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEER 1000
GETEMED MEDIZIN- UND INFORMATIONST510(k) NO: K130785(SPECIAL)
ATTN: BERT  SCHADOW               PHONE NO : 493 328394 270
ODERSTRASSE 77                    SE DECISION MADE: 26-JUL-13
TELTOW    GM 14513                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS
GEBR. BRASSELER GMBH & CO. KG     510(k) NO: K131264(TRADITIONAL)
ATTN: ERELA  DANA                 PHONE NO : 202 552 5800   
1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 26-JUL-13
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
SAUFLON PHARMACEUTICALS, LTD.     510(k) NO: K130331(TRADITIONAL)
ATTN: CHRISTOPHER  SMEJKAL        PHONE NO : 44 208 3224200
49-53 YORK ST.                    SE DECISION MADE: 26-JUL-13
TWICKENHAM, MIDDLESEX    UK TW1-3L510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIRMON SERIES
KUWOTECH CO., LTD                 510(k) NO: K131117(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
1515 E KATELLA AVE UNIT 2115      SE DECISION MADE: 26-JUL-13
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION
KOELIS                            510(k) NO: K131448(TRADITIONAL)
ATTN: LAETITIA  GERVAIS           PHONE NO : 334 766375 87
5 AVENUE DU GRAND SABLON          SE DECISION MADE: 26-JUL-13
LA TRONCHE    FR 38700            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HBA1C CONTROL, LEVEL 1 AND LEVEL 2
RANDOX LABORATORIES, LTD.         510(k) NO: K131999(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 028 944224 13
55 DIAMOND RD.                    SE DECISION MADE: 26-JUL-13
CRUMLIN, COUNTY ANTRIM    UK BT29 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHEMOLOCK, CHEMOLOCK PORT
ICU MEDICAL INC                   510(k) NO: K131549(TRADITIONAL)
ATTN: KATHERINE  KENNER           PHONE NO : 801 264 1702   
4455 ATHERTON DRIVE               SE DECISION MADE: 26-JUL-13
SALT LAKE CITY UT 84123           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM
EUROTROL B.V.                     510(k) NO: K131595(TRADITIONAL)
ATTN: PAUL  KOOIJMANS             PHONE NO : 31 318 695777
KEPLERLAAN 20                     SE DECISION MADE: 26-JUL-13
EDE    NL NL 6716 BS              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
IBI ISRAEL BIOMEDICAL INNOVATIONS 510(k) NO: K130059(TRADITIONAL)
ATTN: ELISSA  BURG                PHONE NO : 972 462771 66107
1914 J.N. PEASE PLACE             SE DECISION MADE: 29-JUL-13
CHARLOTTE NC 28262                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
COVIDIEN                          510(k) NO: K131361(TRADITIONAL)
ATTN: STACEY A STRAND             PHONE NO : 303 305 2631   
6135 GUNBARREL AVE.               SE DECISION MADE: 29-JUL-13
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANGIOJET ULTRA POWER PULSE KIT
MEDRAD, INC.                      510(k) NO: K130381(TRADITIONAL)
ATTN: AMRA  RACIC                 PHONE NO : 763 450 8500   
9055 EVERGREEN BLVD NW            SE DECISION MADE: 29-JUL-13
MINNEAPOLIS MN 55433 8003         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPHTACATH KIT
FRANCE CHIRURGAE INSTRUMENTATION  510(k) NO: K123831(TRADITIONAL)
ATTN: BARBARA S FANT              PHONE NO : 513 961 8200   
3308 JEFFERSON AVE UPPER LEVEL    SE DECISION MADE: 29-JUL-13
CINCINNATI OH 45220               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTIFIX S KNOTLESS FIXATION DEVICE
ARTHOCARE CORPORATION             510(k) NO: K131182(TRADITIONAL)
ATTN: MITCHELL  DHORITY           PHONE NO : 512 358 5995   
7000 WEST WILLIAM CANNON DRIVE    SE DECISION MADE: 29-JUL-13
AUSTIN TX 78735                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PTFE SUPER SHEATH INTRODUCER
MARTECH MEDICAL PRODUCTS          510(k) NO: K130855(TRADITIONAL)
ATTN: ALEXIS  ERAZO               PHONE NO : 215 256 4201   
1500 DELP DR.                     SE DECISION MADE: 29-JUL-13
HARLEYSVILLE PA 19438 2900        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MERIT HYDROPHILIC GUIDE WIRE
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K131710(SPECIAL)
ATTN: MARTHA  FOLAN               PHONE NO : 353 91 703700
PARKMORE BUSINESS PARK WEST       SE DECISION MADE: 29-JUL-13
GALWAY    EI EI                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM
CELLO PARTNERSHIP D/B/A VERIZON WI510(k) NO: K122458(TRADITIONAL)
ATTN: CARLOS  GONZALEZ            PHONE NO : 952 209 6605   
ONE VERIZON WAY                   SE DECISION MADE: 30-JUL-13
BASKING RIDGE NJ 07920            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BROADMASTER HEALTHCARE SYSTEM
BROADMASTER BIOTECH CORPORATION   510(k) NO: K130621(TRADITIONAL)
ATTN: ROGER  LAI                  PHONE NO : 886 987111 105
7F, NO. 168-2, LIANCHENG          SE DECISION MADE: 30-JUL-13
ZHONGHE CITY    TW 23553          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT
SPINEVISION, S.A.                 510(k) NO: K130302(SPECIAL)
ATTN: HELENE  PLAS                PHONE NO : 33 153 332525
ANTONY PARC II - 10 PLACE DU GENERSE DECISION MADE: 30-JUL-13
ANTONY CEDEX    FR 92184          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM
MEDAPPS INC., DBA ALERE CONNECT   510(k) NO: K124000(TRADITIONAL)
ATTN: KENT  DICKS                 PHONE NO : 480 305 6323   
8767 E. VIA DE VENTURA, STE 300   SE DECISION MADE: 30-JUL-13
SCOTTSDALE AZ 85258               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CURA COMPENSATOR
CURA MEDICAL TECHNOLOGIES, LLC    510(k) NO: K131150(TRADITIONAL)
ATTN: THOMAS H FARIS              PHONE NO : 650 996 1192   
23 RANCHO CIRCLE                  SE DECISION MADE: 30-JUL-13
LAKE FOREST CA 92630              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COALITION SPACER
GLOBUS MEDICAL, INC.              510(k) NO: K131449(TRADITIONAL)
ATTN: CHRISTINA  KICHULA          PHONE NO : 610 930 1800   
2560 General Armistead Ave VALLEY SE DECISION MADE: 30-JUL-13
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROBLATE(TM) SYSTEM
MONTERIS MEDICAL, INC.            510(k) NO: K131955(SPECIAL)
ATTN: CRAIG  COOMBS               PHONE NO : 510 337 0140   
1193 SHERMAN ST                   SE DECISION MADE: 30-JUL-13
ALAMEDA CA 94501                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP
MEDTRONIC INC.                    510(k) NO: K132008(SPECIAL)
ATTN: MICHELE  MACHACEK           PHONE NO : 763 526 2382   
8200 CORAL  SEA STREET            SE DECISION MADE: 30-JUL-13
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABL90 FLEX
RADIOMETER MEDICAL APS            510(k) NO: K130144(SPECIAL)
ATTN: MARTIN  GABLER              PHONE NO : 45 3827 3114
AKANDEVEJ 21                      SE DECISION MADE: 31-JUL-13
BRONSHOJ    DA DK-2700            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 5F DIGNITY CT TITANIUM PORT
MEDICAL COMPONENTS INC            510(k) NO: K130923(TRADITIONAL)
ATTN: SARAH  SHAFFER              PHONE NO : 215 256 4201   
1499 DELP DRIVE                   SE DECISION MADE: 31-JUL-13
HARLEYSVILLE PA 19438             510(k) STATEMENT

DEVICE: OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES
MATRIX SURGICAL USA               510(k) NO: K123908(TRADITIONAL)
ATTN: JULIE  STEPHENS             PHONE NO : 678 513 0465   
111 LAUREL RIDGE DRIVE            SE DECISION MADE: 31-JUL-13
ALPHARETTA GA 30004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NMI PICC III CATHETER, NMI HPICC III CATHETER
NAVILYST MEDICAL, INC.            510(k) NO: K131942(SPECIAL)
ATTN: LORRAINE M HANLEY           PHONE NO : 508 658 7945   
26 FOREST STREET                  SE DECISION MADE: 31-JUL-13
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIAL CONNECTOR 13MM CLOSED COLLAR
MEDIMOP MEDICAL PROJECTS, LTD.    510(k) NO: K132040(SPECIAL)
ATTN: ILANIT  GOLDGRABER          PHONE NO : 972 9 7778666
17 HATIDHAR ST.                   SE DECISION MADE: 31-JUL-13
RA'ANANA    IS 4366519            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX SPEEDCINCH
ARTHREX, INC.                     510(k) NO: K132043(SPECIAL)
ATTN: LEON  BROWN II, PH.D.       PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 31-JUL-13
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REXTAR X
META BIOMED, INC.                 510(k) NO: K132041(SPECIAL)
ATTN: BLIX  WINSTON               PHONE NO : 301 601 9185   
2600 MULLINIX MILL ROAD           SE DECISION MADE: 31-JUL-13
MT. AIRY MD 21771                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER
AMECO MEDICAL INDUSTRIES          510(k) NO: K131814(SPECIAL)
ATTN: RAY  KELLY                  PHONE NO : 203 400 7566   
57 LAZY BROOK RD.                 SE DECISION MADE: 26-JUL-13
MONROE CT 03468                   510(k) STATEMENT

DEVICE: COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY
COOK, INC.                        510(k) NO: K122091(TRADITIONAL)
ATTN: SEAN  SPENCE                PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 29-JUL-13
Blmgtn IN 47404                   510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   242                                     
                                                 TOTAL WITH SUMMARIES        225                                     
                                                 TOTAL WITH STATEMENTS        17
                                      

Page Last Updated: 01/13/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.