• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

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