• 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

June 2013 510(k) Clearances

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


DEVICE: HUMAN CAERULOPLASMIN KIT
THE BINDING SITE GROUP, LTD.      510(k) NO: K122965(TRADITIONAL)
ATTN: JILL  CONSTANTINE           PHONE NO : 440 0 1214569500
8 CALTHORPE ROAD WEST MIDLANDS    SE DECISION MADE: 03-JUN-13
EDGBASTON    UK B15 1QT           510(k) STATEMENT

DEVICE: VIDAS LYME IGM
BIOMERIEUX SA                     510(k) NO: K122979(TRADITIONAL)
ATTN: CATHERINE  FRITSCH          PHONE NO : 33 47 8872398
CHEMIN DE L ORME                  SE DECISION MADE: 04-JUN-13
MARCY L ETOILE    FR 69280        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT
MERIDIAN BIOSCIENCE, INC.         510(k) NO: K123423(TRADITIONAL)
ATTN: MICHELLE L SMITH            PHONE NO : 513 271 3700   
3471 RIVER HILLS DRIVE            SE DECISION MADE: 05-JUN-13
CINCINNATI OH 45244               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABBOTT CARBAMAZEPINE ASSAY
MICROGENICS CORPORATION           510(k) NO: K123518(TRADITIONAL)
ATTN: KAREN  LEE                  PHONE NO : 510 979 5000   
46360 FREMONT BLVD.               SE DECISION MADE: 05-JUN-13
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K120945(TRADITIONAL)
ATTN: ERIKA B AMMIRATI, RAC, MT(ASPHONE NO : 650 949 2768   
575 SHIRLYNN COURT                SE DECISION MADE: 07-JUN-13
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K131051(TRADITIONAL)
ATTN: ERIKA  AMMIRATI             PHONE NO : 650 949 2768   
575 SHIRLYNN COURT                SE DECISION MADE: 07-JUN-13
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K131217(TRADITIONAL)
ATTN: ERIKA  AMMIRATI             PHONE NO : 650 949 2768   
575 SHIRLYNN COURT                SE DECISION MADE: 07-JUN-13
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
DIAZYME LABORATORIES              510(k) NO: K123785(TRADITIONAL)
ATTN: ABHIJIT  DATTA              PHONE NO : 858 455 4762   
12889 GREGG COURT                 SE DECISION MADE: 07-JUN-13
POWAY CA 92064                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
EUROIMMUN US                      510(k) NO: K123261(TRADITIONAL)
ATTN: KATHRYN  KOHL               PHONE NO : 973 656 1000   
1100 THE AMERICAN ROAD            SE DECISION MADE: 12-JUN-13
MORRIS PLAINS NJ 07950            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIN MULTI-DRUG SCREEN TEST CASSETTE, DIP CARD AND CUP
ADVIN BIOTECH                     510(k) NO: K122809(TRADITIONAL)
ATTN: EDWARD  TUNG                PHONE NO : 858 668 8305   
6861 NANCY RIDGE DR.              SE DECISION MADE: 17-JUN-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOFIA STREP A FIA
QUIDEL CORPORATION                510(k) NO: K123793(TRADITIONAL)
ATTN: JOHN D TAMERIUS, PH.D.      PHONE NO : 858 552 7908   
10165 MCKELLAR COURT              SE DECISION MADE: 17-JUN-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS
MICOBIOMED CO, LTD                510(k) NO: K123016(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
55-13, SINGEONJI-DONG             SE DECISION MADE: 18-JUN-13
ANSEONG    KS 456-781             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D
IMMUNODIAGNOSTIC SYSTEMS LTD.     510(k) NO: K123253(TRADITIONAL)
ATTN: MICK  FENTON                PHONE NO : 44 191 5190660
10 DIDCOT WAY, BOLDEN BUSINESS PARSE DECISION MADE: 18-JUN-13
BOLDON, TYNE & WEAR    UK NE35 9PD510(k) STATEMENT

DEVICE: VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM
MICOBIOMED CO, LTD                510(k) NO: K123007(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
55-13, SINGEONJI-DONG             SE DECISION MADE: 19-JUN-13
ANSEONG    KS 456-781             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HUMAN ALBUMIN CSF KIT
THE BINDING SITE GROUP, LTD.      510(k) NO: K121045(TRADITIONAL)
ATTN: JILL  CONSTANTINE           PHONE NO : 440 121456 9500
8 CALTHORPE ROAD                  SE DECISION MADE: 19-JUN-13
EDGBASTON    UK B15 1QT           510(k) STATEMENT

DEVICE: XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE
CEPHEID                           510(k) NO: K130894(TRADITIONAL)
ATTN: RAINER  ZIERMANN PH.D.      PHONE NO : 408 400 4425   
904 CARIBBEAN DRIVE               SE DECISION MADE: 20-JUN-13
SUNNYVALE CA 94089 1189           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT - 60 PLATE, AND SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE
ASTORIA-PACIFIC,INC.              510(k) NO: K121101(TRADITIONAL)
ATTN: CHARLES A PETERSON          PHONE NO : 503 657 3010   
15130 S.E. 82ND DR.               SE DECISION MADE: 20-JUN-13
CLACKAMAS OR 97015                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
BIOFIRE DIAGNOSTICS, INC.         510(k) NO: K130914(TRADITIONAL)
ATTN: BETH  LINGENFELTER          PHONE NO : 801 736 6354   
390 WAKARA WAY                    SE DECISION MADE: 21-JUN-13
SALT LAKE CITY UT 84108           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.
LK CONSULTING GROUP               510(k) NO: K130295(SPECIAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 844 2612   
1515 E KATELLA AVE. UNIT 2115     SE DECISION MADE: 21-JUN-13
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY  PHENCYCLIDINE
OMEGA LABORATORIES, INC.          510(k) NO: K131181(TRADITIONAL)
ATTN: ROBERT J BARD, JD, RAC, CQE PHONE NO : 248 563 5040   
400 NORTH CLEVELAND               SE DECISION MADE: 25-JUN-13
MOGADORE OH 44260                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN
BECTON, DICKINSON AND COMPANY     510(k) NO: K123266(TRADITIONAL)
ATTN: MONICA E GIGUERE            PHONE NO : 410 316 4287   
7 LOVETON CIRCLE, MC 614          SE DECISION MADE: 26-JUN-13
SPARKS MD 21152                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
ABBOTT DIABETES CARE              510(k) NO: K130094(TRADITIONAL)
ATTN: DAVID G LAMBERT             PHONE NO : 510 749 5105   
1360 SOUTH LOOP RD                SE DECISION MADE: 27-JUN-13
ALAMEDA CA 94502                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)
BECTON, DICKINSON & CO.           510(k) NO: K123404(TRADITIONAL)
ATTN: MONICA E GIGURERE           PHONE NO : 410 316 4287   
7 LOVETON CIR.                    SE DECISION MADE: 27-JUN-13
SPARKS MD 21152 0999              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMUNOCAP ALLERGEN I3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN 14, PAPER WASP VENOM
PHADIA AB                         510(k) NO: K123275(TRADITIONAL)
ATTN: MARTIN  MANN                PHONE NO : 269 492 1957   
4169 COMMERCIAL AVENUE            SE DECISION MADE: 28-JUN-13
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2
HILL-ROM                          510(k) NO: K122473(TRADITIONAL)
ATTN: ANN  WATERHOUSE             PHONE NO : 812 931 2634   
1069 STATE ROUTE 46 EAST          SE DECISION MADE: 03-JUN-13
BATESVILLE IN 47006               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER
FOOTPRINT MEDICAL INC.            510(k) NO: K130507(SPECIAL)
ATTN: CLYDE N BAKER               PHONE NO : 210 226 2600   
12727 CIMARRON PATH               SE DECISION MADE: 03-JUN-13
SAN ANTONIO TX 78249              510(k) STATEMENT

DEVICE: VALVED TEARAWAY INTRODUCER GENERATION II
MEDICAL COMPONENTS INC            510(k) NO: K124046(TRADITIONAL)
ATTN: TIMOTHY  HOLWICK            PHONE NO : 215 256 4201   
1499 DELP DRIVE                   SE DECISION MADE: 03-JUN-13
HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
BISCO, INC.                       510(k) NO: K123653(TRADITIONAL)
ATTN: MICHELLE  SCHILTZ-TAING     PHONE NO : 847 534 6146   
1100 WEST IRVING PARK RD.         SE DECISION MADE: 03-JUN-13
Schaumburg IL 60193               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR
OSTEOMED LP                       510(k) NO: K123885(TRADITIONAL)
ATTN: PIEDAD  PENA                PHONE NO : 972 677 4784   
3885 Arapaho Rd                   SE DECISION MADE: 03-JUN-13
ADDISON TX 75001                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRACHECK CURVE BLOOD PRESSURE CUFFS
STATCORP MEDICAL                  510(k) NO: K122365(TRADITIONAL)
ATTN: WAYNE  EMMERT               PHONE NO : 904 786 5113   
14476 Duval Pl W Ste 303          SE DECISION MADE: 04-JUN-13
JACKSONVILLE FL 32218             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LYOPLANT ONLAY
AESCULAP, INC.                    510(k) NO: K122791(TRADITIONAL)
ATTN: DENISE  ADAMS               PHONE NO : 610 984 9076   
3773 CORPORATE PARKWAY            SE DECISION MADE: 04-JUN-13
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K130640(TRADITIONAL)
ATTN: KRISTI  FRISCH              PHONE NO : 800 876 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 04-JUN-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFILL OBLIQUE TLIF DEVICE
PINNACLE SPINE GROUP, LLC         510(k) NO: K124012(TRADITIONAL)
ATTN: REBECCA K PINE              PHONE NO : 760 809 5178   
1601 ELM ST STE 1930              SE DECISION MADE: 04-JUN-13
Dallas TX 75201                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE
INTEL-GE CARE INNOVATIONS LLC     510(k) NO: K130290(TRADITIONAL)
ATTN: MAUREEN  GLYNN              PHONE NO : 916 847 7794   
3721 DOUGLAS BOULEVARD SUITE 100  SE DECISION MADE: 04-JUN-13
ROSEVILLE CA 95661                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEMPUS PRO PATIENT MONITOR
REMOTE DIAGNOSTIC TECHNOLOGIES LTD510(k) NO: K130773(TRADITIONAL)
ATTN: CHRIS  HANNAN               PHONE NO : 44 1256 362400
THE OLD COACH HOUSE, THE AV. FARLESE DECISION MADE: 05-JUN-13
HAMPSHIRE    UK RG25 2HT          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TRC-50DX RETINAL CAMERA
TOPCON MEDICAL SYSTEMS, INC.      510(k) NO: K123101(TRADITIONAL)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 05-JUN-13
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROEPG SYSTEM
STROHL MEDICAL TECHNOLOGIES       510(k) NO: K123843(TRADITIONAL)
ATTN: JIM  GRECO                  PHONE NO : 603 401 0072   
8 GRAY LODGE RD                   SE DECISION MADE: 05-JUN-13
KITTERY ME 03904                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NOBELPROCERA PEEK ABUTMENTS
NOBEL BIOCARE AB                  510(k) NO: K120954(TRADITIONAL)
ATTN: PHUONG NGUYEN  SON          PHONE NO : 714 282 4800   
22715 SAVI RANCH PKWY.            SE DECISION MADE: 05-JUN-13
YORBA LINDA CA 92887              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER
INSPIRX, INC.                     510(k) NO: K130598(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 05-JUN-13
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEARTSTRING III PROXIMAL SEAL SYSTEM
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K130382(TRADITIONAL)
ATTN: MARK  DINGER                PHONE NO : 973 709 7691   
45 BARBOUR POND DRIVE             SE DECISION MADE: 05-JUN-13
Wayne NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA       510(k) NO: K131321(SPECIAL)
ATTN: LAUREN  KAMER               PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 05-JUN-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHOTON PHOTON PLUS
ZOLAR TECHNOLOGY & MFG. CO. INC.  510(k) NO: K122020(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 516 482 9001   
55 NORTHERN BLVD SUITE 200        SE DECISION MADE: 05-JUN-13
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: F&P SIMPLUS FULL FACE MASK
FISHER & PAYKEL HEALTHCARE LIMITED510(k) NO: K130328(TRADITIONAL)
ATTN: SUE  CHO                    PHONE NO : 64 9 5740100
15 MAURICE PAYKEL PLACE EAST TAMAKSE DECISION MADE: 05-JUN-13
AUCKLAND    NZ 2013               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC. 510(k) NO: K130427(TRADITIONAL)
ATTN: SARAH  MCINTYRE             PHONE NO : 906 225 5861   
375 RIVER PARK CIRCLE             SE DECISION MADE: 05-JUN-13
MARQUETTE MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WART FREEZE
KONINKLIJKE UTERMOHLEN NV         510(k) NO: K130599(SPECIAL)
ATTN: KENNETH R MICHAEL           PHONE NO : 858 382 1331   
11956 BERNARDO PLAZA DR. #417     SE DECISION MADE: 05-JUN-13
SAN DIEGO CA 92128 1317           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRITICAL CARE VENTILATOR
ORICARE, INC.                     510(k) NO: K120931(TRADITIONAL)
ATTN: DAVID  JAMISON              PHONE NO : 215 538 2470   
1900 AM DRIVE                     SE DECISION MADE: 06-JUN-13
QUAKERTOWN PA 18951               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K131346(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 949 706 7456   
55 NORTHERN BLVD., SUITE 200      SE DECISION MADE: 06-JUN-13
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K130739(TRADITIONAL)
ATTN: SHELLY  PEARCE              PHONE NO : 650 694 5988   
685 East Middlefield Road         SE DECISION MADE: 06-JUN-13
Mountain View CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
SORIN GROUP ITALIA S.R.L.         510(k) NO: K131103(SPECIAL)
ATTN: SCOTT  LIGHT                PHONE NO : 303 467 6313   
14401 W. 65TH WAY                 SE DECISION MADE: 06-JUN-13
ARVADA CO 80004                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K130149(TRADITIONAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 357 73351X2212
NO 57, PARK AVE 2, SCIENCE PARK   SE DECISION MADE: 06-JUN-13
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WIZARD 230 NASAL PILOW MASK
APEX MEDICAL CORP.                510(k) NO: K121642(TRADITIONAL)
ATTN: FRANK  LIN                  PHONE NO : 886 222 685568
NO. 9, MINSHENG STREET            SE DECISION MADE: 06-JUN-13
TUCHENG CITY, TAIPEI COUNTY    TW 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUILION PRIME, V5.00
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K130645(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DRIVE               SE DECISION MADE: 06-JUN-13
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NATRATONE
ORELLE CORPORATION LTD            510(k) NO: K121902(TRADITIONAL)
ATTN: PATRICIA  COOMBES           PHONE NO : 206 420 4703   
4739 - 44TH AVE S.W., UNIT 403    SE DECISION MADE: 06-JUN-13
SEATTLE WA 98116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DAS MEDICAL EQUIPMENT DRAPES
DAS MEDICAL, LLC                  510(k) NO: K121436(TRADITIONAL)
ATTN: ARMOND  GROVES              PHONE NO : 662 497 2866   
100 ROSECREST LANE                SE DECISION MADE: 06-JUN-13
COLUMBUS MS 39701                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING
CORELEADER BIOTECH CO., LTD.      510(k) NO: K123394(TRADITIONAL)
ATTN: VINCENT  HUANG              PHONE NO : 886 2 26968880
19F NO. 100, SEC 1 SINTAI 5TH RD, SE DECISION MADE: 06-JUN-13
NEW TAIPEI, TAIWAN    TW 22102    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VECTOR PTA BALLOON DILATATION CATHETER
R4 VASCULAR, INC.                 510(k) NO: K131329(SPECIAL)
ATTN: LAURIE  LEWANDOWSKI         PHONE NO : 612 771 4038   
738 SADDLE WOOD DR.               SE DECISION MADE: 06-JUN-13
EAGAN MN 55123                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
CONVATEC INC                      510(k) NO: K123481(TRADITIONAL)
ATTN: KATRINA  FIEDLER            PHONE NO : 908 904 2541   
200 HEADQUARTERS PARK DRIVE       SE DECISION MADE: 06-JUN-13
SKILLMAN NJ 08558                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FASTBRACES CERAMIC BRACKETS
ORTHODONTIC DESIGN AND PRODUCTION,510(k) NO: K130446(TRADITIONAL)
ATTN: RICHARD  MERRELL            PHONE NO : 760 734 3995   
1370 DECISION STREET SUITE D      SE DECISION MADE: 07-JUN-13
VISTA CA 92081                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
CARESTREAM HEALTH,INC.            510(k) NO: K130464(TRADITIONAL)
ATTN: CAROLYN  WAGNER             PHONE NO : 585 627 6588   
150 VERONA STREET                 SE DECISION MADE: 07-JUN-13
ROCHESTER NY 14608                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
ACCESS SCIENTIFIC, LLC            510(k) NO: K131300(SPECIAL)
ATTN: ALBERT  MISAJON             PHONE NO : 858 259 8333   
3910 Sorrento Valley Blvd Ste 200 SE DECISION MADE: 07-JUN-13
San Diego CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISR'OBOT MONA LISA
BIOBOT SURGICAL PTE LTD           510(k) NO: K130944(SPECIAL)
ATTN: JOHN  BABY                  PHONE NO : 65 3150 7191
20 MAXWELL ROAD, #09-17, MAXWELL HSE DECISION MADE: 07-JUN-13
SINGAPORE    SN 069113            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TELERADPRO EDGE; TELERADPRO EDGE HD-CCD
VIDAR SYSTEMS CORP.               510(k) NO: K130636(TRADITIONAL)
ATTN: CARRIE L BRANCART           PHONE NO : 703 471 7070   
365 Herndon Pkwy                  SE DECISION MADE: 07-JUN-13
HERNDON VA 20170                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4WEB OSTEOTOMY BONE WEDGE
4-WEB, INC.                       510(k) NO: K130185(TRADITIONAL)
ATTN: RICH  JANSEN, PHARM, D.     PHONE NO : 612 281 5505   
13540 GUILD AVE.                  SE DECISION MADE: 07-JUN-13
APPLE VALLEY MN 55124             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEARING NSPVA EMBOLIZATION PARTICLES
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K130259(TRADITIONAL)
ATTN: LINDA  VARROSO              PHONE NO : 781 681 7963   
1050 HINGHAM ST                   SE DECISION MADE: 07-JUN-13
ROCKLAND MA 02370                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIMACORPORATE SMR CTA HUMERAL HEADS
LIMACORPORATE S.P.A.              510(k) NO: K131112(SPECIAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 574 527 4220   
P.O. BOX 696                      SE DECISION MADE: 07-JUN-13
WINONA LAKE IN 46590 696          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMR SOFTWARE APPLICATION
PHILIPS HEALTHCARE (CLEVELAND)    510(k) NO: K123576(TRADITIONAL)
ATTN: CHRISTINE  ANDERSON         PHONE NO : 440 483 7732   
595 MINER RD.                     SE DECISION MADE: 07-JUN-13
CLEVELAND OH 44143                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRELUDE SHEATH INTRODUCER
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K130791(SPECIAL)
ATTN: MICHAELA  RIVKOWICH         PHONE NO : 801 208 4196   
1600 WEST MERIT PKWY.             SE DECISION MADE: 07-JUN-13
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XGEO GU60
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K123105(TRADITIONAL)
ATTN: CHARLIE  MACK               PHONE NO : 541 376 5063   
77325 JOYCE WAY                   SE DECISION MADE: 07-JUN-13
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE
NDS SURGICAL IMAGING              510(k) NO: K131115(SPECIAL)
ATTN: JIM  LENG                   PHONE NO : 408 776 0085   
5750 HELLYER AVENUE               SE DECISION MADE: 07-JUN-13
SAN JOSE CA 95138                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE 330PSI EXTENSION LINES
COEUR, INC.                       510(k) NO: K120892(TRADITIONAL)
ATTN: DEBRA F MANNING             PHONE NO : 615 547 7923   
100 PHYSICIANS WAY SUITE 200      SE DECISION MADE: 10-JUN-13
LEBANON TN 37090                  510(k) STATEMENT

DEVICE: ACUMED TOTALW RIST FUSION PLATING SYSTEM
ACUMED LLC                        510(k) NO: K131380(SPECIAL)
ATTN: BRITTANY  CUNNINGHAM        PHONE NO : 503 207 1467   
5885 NW CORNELIUS PASS RD.        SE DECISION MADE: 10-JUN-13
HILLSBORO OR 97124 9432           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
STRYKER TRAUMA AG                 510(k) NO: K130907(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461   
325 CORPORATE DRIVE               SE DECISION MADE: 10-JUN-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STARBAND
ORTHOMERICA PRODUCTS, INC.        510(k) NO: K124023(TRADITIONAL)
ATTN: DAVID L HOOPER              PHONE NO : 407 290 6592   
6333 N Orange Blossom Trl         SE DECISION MADE: 10-JUN-13
ORLANDO FL 32810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: T3
MEDCOMP                           510(k) NO: K123292(TRADITIONAL)
ATTN: TIMOTHY  HOLWICK            PHONE NO : 215 256 4201   
1499 DELP DR.                     SE DECISION MADE: 11-JUN-13
HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONENDO ENDOTHERAPY SYSTEM
SONENDO, INC.                     510(k) NO: K130025(TRADITIONAL)
ATTN: DAN W MILLER                PHONE NO : 949 766 3636   
26061 MERIT CIRCLE, SUITE 101     SE DECISION MADE: 11-JUN-13
LAGUNA HILLS CA 92653             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENGLER 25K SERIES ULTRASONIC INSERTS
ENGLER ENGINEERING CORP.          510(k) NO: K122748(TRADITIONAL)
ATTN: JOEL  KATZ                  PHONE NO : 305 688 8581   
1099 EAST 47TH ST.                SE DECISION MADE: 11-JUN-13
HIALEAH FL 33013                  510(k) STATEMENT

DEVICE: DISPOSABLE CIRCULAR STAPLER
CHANGZHOU CITY ZHIYE MEDICAL DEVIC510(k) NO: K131303(TRADITIONAL)
ATTN: CHARLIE  MACK               PHONE NO : 931 625 4938   
12226 WASHINGTON LANE             SE DECISION MADE: 11-JUN-13
PARKER AZ 85344                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAMMOMAT INSPIRATION PRIME
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123520(TRADITIONAL)
ATTN: PATRICIA D JONES            PHONE NO : 610 448 3536   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 11-JUN-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATHASSIST LED LIGHT FIBER
ENTELLUS MEDICAL, INC.            510(k) NO: K130503(TRADITIONAL)
ATTN: KAREN E PETERSON            PHONE NO : 763 463 7066   
3600 HOLLY LANE NORTH SUITE 40    SE DECISION MADE: 11-JUN-13
PLYMOUTH MN 55447                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREVENT SEAL
ITENA CLINICAL                    510(k) NO: K122521(TRADITIONAL)
ATTN: LOUIS-PAUL  MARIN           PHONE NO : 514 928 5546
500 BOUL CARTIER WEST             SE DECISION MADE: 11-JUN-13
LAVAL    CA H7V 5B7               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DR LONG LENGTH IMAGING SOFTWARE
CARESTREAM HEALTH, INC.           510(k) NO: K130567(TRADITIONAL)
ATTN: CAROLYN  WAGNER             PHONE NO : 585 627 6588   
150 VERONA STREET                 SE DECISION MADE: 11-JUN-13
ROCHESTER NY 14608                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K131528(TRADITIONAL)
ATTN: AMANDA  STAHLE              PHONE NO : 319 248 6628   
102 FIRST ST. SOUTH               SE DECISION MADE: 11-JUN-13
Kalona IA 52247                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Z-800 INFUSION SYSTEM
ZYNO MEDICAL LLC                  510(k) NO: K130690(SPECIAL)
ATTN: MEI  ZHANG PHD              PHONE NO : 508 650 2008   
177 PINE ST                       SE DECISION MADE: 12-JUN-13
NATICK MA 01760                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
MEDGYN PRODUCTS, INC.             510(k) NO: K122973(TRADITIONAL)
ATTN: STEPHANIE  BLAIR            PHONE NO : 408 286 8933   
12 SOUTH FIRST STREE 12TH FLOOR   SE DECISION MADE: 12-JUN-13
SAN JOSE CA 95113                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINT
HANSBIOMED CORPORATION            510(k) NO: K130191(TRADITIONAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N PUENTE ST UNIT B            SE DECISION MADE: 12-JUN-13
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VUSION CS PLUS
ORTHO DEVELOPMENT CORP.           510(k) NO: K122588(TRADITIONAL)
ATTN: TOM  HAUETER                PHONE NO : 801 553 9991   
12187 SOUTH BUSINESS PARK DR.     SE DECISION MADE: 12-JUN-13
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMR 3-PEGS GLENOIDS
LIMACORPORATE S.P.A.              510(k) NO: K130642(TRADITIONAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 574 527 4220   
P.O. BOX 696                      SE DECISION MADE: 12-JUN-13
WINONA LAKE IN 46590 696          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXUS TKO-6P LUER ACTIVATED DEVICE
NEXUS MEDICAL, LLC                510(k) NO: K130416(TRADITIONAL)
ATTN: HEATHER  TURNER             PHONE NO : 913 451 2234   
11315 STRANG LINE ROAD            SE DECISION MADE: 12-JUN-13
LENEXA KS 66215                   510(k) STATEMENT

DEVICE: SHASER V-MINI HAIR REMOVAL SYSTEM
SHASER, INC.                      510(k) NO: K130015(TRADITIONAL)
ATTN: SARAH  HACKETT              PHONE NO : 781 995 2251   
10 MAGUIRE RD STE 120 BUILDING ONESE DECISION MADE: 13-JUN-13
LEXINGTON MA 02421                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIPELINE TOTAL HIP SYSTEM
PIPELINE ORTHOPEDICS              510(k) NO: K131237(SPECIAL)
ATTN: TERRY  POWELL               PHONE NO : 703 562 9800   
901 KING STREET, SUITE 200        SE DECISION MADE: 13-JUN-13
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENTERAL NUTRITION WARMER
ACACIA, INC.                      510(k) NO: K122449(TRADITIONAL)
ATTN: FERGIE  FERGUSON            PHONE NO : 714 257 0470   
785 CHALLENGER ST.                SE DECISION MADE: 13-JUN-13
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GUIDEWIRE, PURSUER SERIES
OSCOR INC.                        510(k) NO: K130104(TRADITIONAL)
ATTN: MILA  DOSKOCIL              PHONE NO : 727 937 2511   
3816 DE SOTO BLVD.                SE DECISION MADE: 13-JUN-13
PALM HARBOR FL 34683              510(k) STATEMENT

DEVICE: ORTHOSENSOR KNEE BALANCER
ORTHOSENSOR, INC.                 510(k) NO: K130380(SPECIAL)
ATTN: KIMBERLEE  WASHBURN         PHONE NO : 954 577 7770   
1560 SAWGRASS CORPORATE PKWY. 4TH SE DECISION MADE: 13-JUN-13
SUNRISE FL 33323                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLATEAU SPACER SYSTEM TITANIUM
LIFE SPINE, INC                   510(k) NO: K130630(SPECIAL)
ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   
2401 W. HASSELL RD SUITE 1535     SE DECISION MADE: 13-JUN-13
HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE
WATCHDOG GROUP, LC                510(k) NO: K130753(TRADITIONAL)
ATTN: JOHN  O'HARA                PHONE NO : 314 721 5367   
7800 Forsyth Blvd. 8th Floor      SE DECISION MADE: 13-JUN-13
Clayton MO 63105                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTUM DENTAL IMPLANT SYSTEM
QUANTUM BIOENGINEERING, LTD.      510(k) NO: K130787(TRADITIONAL)
ATTN: LINDA  SCHULZ               PHONE NO : 858 792 1235   
12264 EL CAMINO REAL, SUITE 400   SE DECISION MADE: 13-JUN-13
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMIA AUTOMATED PD SYSTEM
DEKA RESEARCH & DEVELOPMENT CORP. 510(k) NO: K124018(TRADITIONAL)
ATTN: ROGER A LEROUX              PHONE NO : 603 669 5139   
340 COMMERCIAL ST.                SE DECISION MADE: 14-JUN-13
MANCHESTER NH 03101               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENFLOW IV FLUID WARMER INSULATED STRAP
VITAL SIGNS, INC., A GE HEALTHCARE510(k) NO: K130867(SPECIAL)
ATTN: STACIE  GEFFNER-ATIYA       PHONE NO : 973 956 5491   
20 CAMPUS RD                      SE DECISION MADE: 14-JUN-13
TOTOWA NJ 07512                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMORY CARDIAC TOOLBOX 3.2
SYNTERMED, INC.                   510(k) NO: K130902(TRADITIONAL)
ATTN: KENNETH  VAN TRAIN          PHONE NO : 888 263 4446   
245 SOUTH OWENS DRIVE             SE DECISION MADE: 14-JUN-13
ANAHEIM CA 92808                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM
CARBOFIX ORTHOPEDICS LTD.         510(k) NO: K123810(TRADITIONAL)
ATTN: YAEL  RUBIN                 PHONE NO : 972 995115 11
11 HA'HOSHLIM STREET              SE DECISION MADE: 14-JUN-13
HERZELIYA    IS 46724             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHABNER XRT GARMENTS
BFFL CO. INC                      510(k) NO: K121284(TRADITIONAL)
ATTN: EVAN P PHELPS               PHONE NO : 202 789 1212   
600 NEW HAMPSHIRE AVENUE NW SUITE SE DECISION MADE: 14-JUN-13
WASHINGTON DC 20037               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMNICUT RESECTION BLADE
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K130912(TRADITIONAL)
ATTN: TATYANA  KORSUNSKY          PHONE NO : 508 828 3122   
325 PARAMOUNT DR.                 SE DECISION MADE: 14-JUN-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
SONOSCAPE COMPANY LIMITED         510(k) NO: K130801(TRADITIONAL)
ATTN: TOKI  WU                    PHONE NO : 86 755 26722890
4/F YIZHE BLDG, YUQUAN ROAD       SE DECISION MADE: 14-JUN-13
SHENZHEN, GUANGDONG    CH 518051  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K130992(TRADITIONAL)
ATTN: DIANE  SUDDUTH              PHONE NO : 512 327 9997   
816 CONGRESS AVE, SUITE 1400      SE DECISION MADE: 14-JUN-13
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K130849(SPECIAL)
ATTN: MARKUS  STACHA              PHONE NO : 49 703146 32840
HEWLETT-PACKARD STR.2             SE DECISION MADE: 14-JUN-13
BOEBLINGEN    GM D 71034          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEL-GEN COLD STORAGE SOLUTION
WATERS MEDICAL SYSTEMS, LLC       510(k) NO: K121618(TRADITIONAL)
ATTN: ROBERT  WARREN              PHONE NO : 800 426 9877   
2112 15TH ST. N.W.                SE DECISION MADE: 14-JUN-13
ROCHESTER MN 55901                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I-MAX TOUCH 3D
OWANDY                            510(k) NO: K130443(ABBREVIATED)
ATTN: CLAUDE  BERTHOIN            PHONE NO : 386 672 0450   
110 E. GRANADA BLVD. SUITE 207    SE DECISION MADE: 14-JUN-13
ORMOND BEACH FL 32176             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODULAP LOOP
ATC TECHNOLOGIES, INC.            510(k) NO: K121343(TRADITIONAL)
ATTN: JOHN  GILLESPIE             PHONE NO : 774 567 0277   
79 HAVEN STREET                   SE DECISION MADE: 14-JUN-13
DOVER MA 02030                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406
MAINE STANDARDS CO.               510(k) NO: K123127(TRADITIONAL)
ATTN: JAMES W CHAMPLIN            PHONE NO : 800 377 9684   
765 ROOSEVELT TRAIL               SE DECISION MADE: 14-JUN-13
WINDHAM ME 04062 5365             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
BECKMAN COULTER, INC.             510(k) NO: K121214(TRADITIONAL)
ATTN: KERRIE  OETTER              PHONE NO : 952 368 7858   
1000 LAKE HAZELTINE DR.           SE DECISION MADE: 14-JUN-13
CHASKA MN 55318 1084              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K130542(TRADITIONAL)
ATTN: JYH-SHYAN  LIN              PHONE NO : 301 251 1092   
419 WEST AVE.                     SE DECISION MADE: 14-JUN-13
STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TORC BODY
JOHARI DIGITAL HEALTHCARE, LTD.   510(k) NO: K131291(SPECIAL)
ATTN: POOJA  JOHARI               PHONE NO : 858 657 9226   
5703 OBERLIN DR. SUITE 306        SE DECISION MADE: 14-JUN-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LASER HELMET
THERADOME INC.                    510(k) NO: K122950(TRADITIONAL)
ATTN: LARRY  PETERSEN             PHONE NO : 303 489 2500   
4900 HOPYARD ROAD SUITE 100       SE DECISION MADE: 14-JUN-13
PLEASANTON CA 94588               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRAXEL DIAL 1550/1927 LASER SYSTEM
SOLTA MEDICAL, INC.               510(k) NO: K130193(TRADITIONAL)
ATTN: RAYMOND  LEE                PHONE NO : 510 259 7159   
25881 Industrial Blvd             SE DECISION MADE: 14-JUN-13
HAYWARD CA 94545                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PG-800A SERIES
SHENZHEN PANGO ELECTRONIC CO., LTD510(k) NO: K131569(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 212281 5850
P.O. BOX 237-023                  SE DECISION MADE: 14-JUN-13
SHANGHAI    CH 200030             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY
NUANCE MEDICAL, LLC               510(k) NO: K130995(TRADITIONAL)
ATTN: MARC S LIEBERMAN            PHONE NO : 760 525 4032   
300 CARLSBAD VILLAGE DRIVE, SUITE SE DECISION MADE: 14-JUN-13
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014" GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018"
TRIREME MEDICAL, INC.             510(k) NO: K130414(TRADITIONAL)
ATTN: SHIVA  ARDAKANI             PHONE NO : 925 931 1300   
7060 Koll Center Parkway Suite 300SE DECISION MADE: 15-JUN-13
Pleasanton CA 94566               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D
DREAMCON CO., LTD                 510(k) NO: K123431(TRADITIONAL)
ATTN: ALBERT  REGO                PHONE NO : 949 770 8710   
27001 LA PAZ ROAD SUITE 312       SE DECISION MADE: 17-JUN-13
MISSION VIEJO CA 92691            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
BIOMET MICROFIXATION              510(k) NO: K130309(TRADITIONAL)
ATTN: CHRISTINE  SCIFERT          PHONE NO : 901 831 8053   
3416 ROXEE RUN COVE               SE DECISION MADE: 17-JUN-13
BARTLETT TN 38133                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VINYL EXAMINATION POWDER FREE GLOVES, CLEAR
WEILIN PLASTIC AND RUBBER PRODUCTS510(k) NO: K123590(TRADITIONAL)
ATTN: LING  ZHU                   PHONE NO : 909 548 4828   
12390 EAST END AVE.               SE DECISION MADE: 17-JUN-13
CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AZUR PUSHABLE 18 & 35 SYSTEM
MICROVENTION, INC.                510(k) NO: K130577(SPECIAL)
ATTN: CYNTHIA  VALENZUELA         PHONE NO : 714 247 8000   
1311 VALENCIA AVE                 SE DECISION MADE: 17-JUN-13
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STELLAR 150
RESMED GERMANY INC.               510(k) NO: K122715(TRADITIONAL)
ATTN: JIM  CASSI                  PHONE NO : 858 836 6081   
9001 SPECTRUMA CENTER BOULEVARD   SE DECISION MADE: 17-JUN-13
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DURABLUE STERILIZATION WRAP
CARDINAL HEALTH 200, LLC          510(k) NO: K130927(SPECIAL)
ATTN: LAVENIA  FORD               PHONE NO : 847 887 3323   
1430 WAUKEGAN ROAD                SE DECISION MADE: 18-JUN-13
WAUKEGAN IL 60085                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IU22 DIAGNOSTIC ULTRASOUND SYSTEM
PHILIPS ULTRASOUND, INC.          510(k) NO: K130499(TRADITIONAL)
ATTN: JESSICA  STENBERG           PHONE NO : 425 487 7371   
22100 BOTHELL EVERETT HWY.        SE DECISION MADE: 18-JUN-13
BOTHELL WA 98021 8431             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TITAN REVERSE SHOULDER SYSTEM
ASCENSION ORTHOPEDIC              510(k) NO: K130050(TRADITIONAL)
ATTN: SUSAN  WALTON               PHONE NO : 512 836 5001   
8700 CAMERON RD., STE. 100        SE DECISION MADE: 18-JUN-13
Austin TX 78754                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM
TACTILE SYSTEMS TECHNOLOGY INC    510(k) NO: K131193(TRADITIONAL)
ATTN: DAVE  HALVERSON             PHONE NO : 612 355 5100   
1331 Tyler St NE Ste 200          SE DECISION MADE: 18-JUN-13
MINNEAPOLIS MN 55413              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIKY UP
ENDOCONTROL                       510(k) NO: K122820(TRADITIONAL)
ATTN: HUGUEL  CARINE              PHONE NO : 334 766 37582
5 AVENUE DU GRAND SABLON          SE DECISION MADE: 18-JUN-13
LA TRONCHE    FR 38700            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
EVENFLO FEEDING INCORPORATED      510(k) NO: K131153(TRADITIONAL)
ATTN: WADE  HALMA                 PHONE NO : 513 870 1629   
9277 Centre Pointe Dr Ste 160     SE DECISION MADE: 18-JUN-13
West Chester OH 45069             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VIVO 50
GE HEALTHCARE, BREAS MEDICAL AB   510(k) NO: K123144(TRADITIONAL)
ATTN: SHLOMI  DELER               PHONE NO : 972 989154 07
FORETAGSVAGEN 1                   SE DECISION MADE: 18-JUN-13
MOLNLYCKE    SW 435 33            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTI LEAD TRIAL CABLE
ST. JUDE MEDICAL                  510(k) NO: K130545(TRADITIONAL)
ATTN: LAKSHMI  PADMANABHAN        PHONE NO : 972 526 8262   
6901 PRESTON ROAD                 SE DECISION MADE: 18-JUN-13
PLANO TX 75024                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
HEALTH & LIFE CO., LTD.           510(k) NO: K130563(TRADITIONAL)
ATTN: SARAH  SU                   PHONE NO : 886 28227 1300
9F, NO.186, JIAN YI ROAD          SE DECISION MADE: 18-JUN-13
ZHONGHE DISTRICT, NEW TAIPEI CITY 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
BIOPRO, INC.                      510(k) NO: K130298(TRADITIONAL)
ATTN: AL  LIPPINCOTT              PHONE NO : 952 492 5858   
3150 E. 200TH ST                  SE DECISION MADE: 18-JUN-13
PRIOR LAKE MN 55372               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM
OSTEOMED LP                       510(k) NO: K131445(SPECIAL)
ATTN: BLESSON  ABRAHAM            PHONE NO : 972 677 4795   
3885 Arapaho Rd                   SE DECISION MADE: 18-JUN-13
ADDISON TX 75001                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM
TYSON BIORESEARCH, INC.           510(k) NO: K123087(SPECIAL)
ATTN: WEN-HAI  TSAI               PHONE NO : 886 375859 88
5 F., # 22, KE E. ROAD III SCIENCESE DECISION MADE: 18-JUN-13
CHUN-NAN, MIAO-LI COUNTY    TW 350510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIVERSAL DISTAL RADIUS SYSTEM
NEWCLIP TECHNICS                  510(k) NO: K130774(SPECIAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD.                SE DECISION MADE: 19-JUN-13
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JOULE 810/940/980 MULTI-PLATFORM SYSTEM
SCITON, INC.                      510(k) NO: K122567(TRADITIONAL)
ATTN: JAY M PATEL                 PHONE NO : 650 493 9155   
925 COMMERCIAL STREET             SE DECISION MADE: 19-JUN-13
Palo Alto CA 94303                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10
GE HEALTHCARE                     510(k) NO: K131267(SPECIAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 W INNOVATION DRIVE           SE DECISION MADE: 19-JUN-13
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLL- V1 LIGHT SOURCE
OLYMPUS WINTER & IBE GMBH         510(k) NO: K130819(TRADITIONAL)
ATTN: SHERI L MUSGNUNG            PHONE NO : 484 896 3147   
3500 CORPORATE PKWAY              SE DECISION MADE: 19-JUN-13
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Z5 DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K130695(TRADITIONAL)
ATTN: WU  ZICUI                   PHONE NO : 86 755 81885635
MINDRAY BUILDING, KEJI 12TH ROAD SSE DECISION MADE: 19-JUN-13
SHENZHEN, GUANGDONG    CH 518057  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3
RANDOX LABORATORIES LIMITED       510(k) NO: K130337(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 440 28 94422413
55 DIAMOND ROAD                   SE DECISION MADE: 19-JUN-13
CRUMLIN, ANTRIM    UK BT29 4QY    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSTEK BLOOD PRESSURE MONITOR
GUANGDONG TRANSTEK MEDICAL ELECTRO510(k) NO: K131395(SPECIAL)
ATTN: LEO  WANG                   PHONE NO : 086 28 86083300
NO.1 FANGHUA STREET, HI-TECH DISTRSE DECISION MADE: 19-JUN-13
CHENGDU, SICHUAN    CH 610041     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BASIXTOUCH
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K130566(SPECIAL)
ATTN: DAN W LINDSAY               PHONE NO : 801 208 4408   
1600 WEST MERIT PKWY.             SE DECISION MADE: 19-JUN-13
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
HEALTH & LIFE CO., LTD.           510(k) NO: K130564(TRADITIONAL)
ATTN: SARAH  SU                   PHONE NO : 886 28227 1300
9F, NO.186, JIAN YI ROAD          SE DECISION MADE: 19-JUN-13
ZHONGHE DISTRICT, NEW TAIPEI CITY 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COALIGN INNOVATIONS ACCULIF XL IBF CAGE
COALIGN INNOVATIONS, INC.         510(k) NO: K131443(SPECIAL)
ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   
1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 19-JUN-13
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRCAST VENAFLOW ELITE SYSTEM
DJO, LLC                          510(k) NO: K130722(TRADITIONAL)
ATTN: LORRI  TROTTER              PHONE NO : 760 734 3049   
1430 DECISION STREET              SE DECISION MADE: 20-JUN-13
VISTA CA 92081 8553               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARROW GPSCATH BALLOON DILATATION CATHETER
HOTSPUR TECHNOLOGIES              510(k) NO: K130397(TRADITIONAL)
ATTN: ERIC  ANKERUD, JD           PHONE NO : 978 302 9467   
880 MAUDE AVENUE SUITE A          SE DECISION MADE: 20-JUN-13
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REFORM PEDICLE SCREW SYSTEM
SPINAL USA                        510(k) NO: K130279(TRADITIONAL)
ATTN: MEREDITH  MAY               PHONE NO : 719 264 9937   
4628 NORTHPARK DRIVE              SE DECISION MADE: 20-JUN-13
COLORADO SPRINGS MS 39208         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUTURABOND  UNIVERSAL
VOCO GMBH                         510(k) NO: K130486(TRADITIONAL)
ATTN: T.  GERKENSMEIER            PHONE NO : 49 4721 719200
ANTON-FLETTNER-STRASSE 1-3        SE DECISION MADE: 20-JUN-13
CUXHAVEN    GM D-27472            510(k) STATEMENT

DEVICE: CELLTRACKS ANALYZER II SYSTEM
VERIDEX, LLC                      510(k) NO: K130794(TRADITIONAL)
ATTN: KIMBERLY  PRESCOTT          PHONE NO : 908 927 4947   
1001 US HIGHWAY 202 NORTH         SE DECISION MADE: 20-JUN-13
RARITAN NJ 08869 0606             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXPEDIUM SPINE SYSTEM
MEDOS INTERNATIONAL SARL          510(k) NO: K130877(TRADITIONAL)
ATTN: KIRSTEN  LEHMULLER          PHONE NO : 508 828 3291   
325 PARAMOUNT DRIVE               SE DECISION MADE: 20-JUN-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TITAN
INTERACOUSTICS A/S                510(k) NO: K130795(TRADITIONAL)
ATTN: ERIK  NIELSEN               PHONE NO : 45 637 13555
DREJERVAENGET 8                   SE DECISION MADE: 20-JUN-13
ASSENS    DA DK-5610              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K123106(TRADITIONAL)
ATTN: CHARLIE  MACK               PHONE NO : 541 376 5063   
77325 JOYCE WAY                   SE DECISION MADE: 20-JUN-13
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
ORTHOPEDIATRICS, CORP.            510(k) NO: K130217(TRADITIONAL)
ATTN: MARK  FOX                   PHONE NO : 574 268 6379   
2850 FRONTIER DRIVE               SE DECISION MADE: 20-JUN-13
WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHYSIOLOGICAL DATA PROCESSOR
ZEPHYR TECHNOLOGY CORPORATION     510(k) NO: K122763(TRADITIONAL)
ATTN: RICHARD  KEEN               PHONE NO : 203 329 2700   
1151 HOPE STREET                  SE DECISION MADE: 20-JUN-13
STAMFORD CT 06907                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
AMERICAN SURGICAL COMPANY, LLC    510(k) NO: K112598(SPECIAL)
ATTN: MICHAEL  ALOUANE            PHONE NO : 781 592 7200   
82 SANDERSON AVENUE               SE DECISION MADE: 20-JUN-13
Lynn MA 01902                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
PROCTER & GAMBLE CO.              510(k) NO: K131543(SPECIAL)
ATTN: KATHLEEN  BLIESZNER         PHONE NO : 513 634 3168   
6110 CENTER HILL AVE.             SE DECISION MADE: 20-JUN-13
CINCINNATI OH 45224               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS)
BEDSIDE CLINICAL SYSTEMS INC      510(k) NO: K124038(TRADITIONAL)
ATTN: DIANE  SUDDUTH              PHONE NO : 512 327 9997   
611 WEST 5TH STREET, THIRD FLOOR  SE DECISION MADE: 21-JUN-13
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ION MAGNUM GENIUS
ION GENIUS INC                    510(k) NO: K123158(TRADITIONAL)
ATTN: XANYA  SOFRA-WEISS          PHONE NO : 808 395 0656   
7192 KALANIANAOLE HWY #D-204A     SE DECISION MADE: 21-JUN-13
HONOLULU HI 96821                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM
INTROMEDIC CO., LTD               510(k) NO: K131131(SPECIAL)
ATTN: STEVE  KWON                 PHONE NO : 408 747 9876   
3550 WILSHIRE BLVD #738           SE DECISION MADE: 21-JUN-13
LOS ANGELES CA 90010 2401         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MFM-CMS CENTRAL MONITORING SYSTEM
EDAN INSTRUMENTS INC              510(k) NO: K120727(TRADITIONAL)
ATTN: RANDY  JIANG                PHONE NO : 867 552 6856469
3/F-B, NANSHAN MEDICAL EQUIPMENTS SE DECISION MADE: 21-JUN-13
SHENZHEN    CH 518067             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)
NEURO RESOURCE GROUP, INC.        510(k) NO: K130816(TRADITIONAL)
ATTN: DAVID  TURNER               PHONE NO : 972 665 1810   
1100 JUPITER RD., STE. 190        SE DECISION MADE: 21-JUN-13
PLANO TX 75074                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
SONOSCAPE COMPANY LIMITED         510(k) NO: K131213(TRADITIONAL)
ATTN: TOKI  WU                    PHONE NO : 86 755267 22890
YIZHE BLDG., YUQUAN RD            SE DECISION MADE: 21-JUN-13
SHENZHEN, GUANGDONG    CH 518051  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERRATA PRESSURE GUIDE WIRE
VOLCANO CORPORATION               510(k) NO: K131288(SPECIAL)
ATTN: JWALA  JAWHARKAR            PHONE NO : 916 281 2925   
2870 KILGORE RD.                  SE DECISION MADE: 21-JUN-13
RANCHO CORDOVA CA 95670           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OAK RIDGE PRODUCTS SHARP CONTAINER
OAK RIDGE PRODUCTS, LLC           510(k) NO: K130281(ABBREVIATED)
ATTN: TIBOR B KOVARI              PHONE NO : 815 363 4700   
4612 Century Ct                   SE DECISION MADE: 21-JUN-13
McHenry IL 60050                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TEZO TITANIUM CAGE FAMILY
ULRICH GMBH & CO. KG              510(k) NO: K122957(TRADITIONAL)
ATTN: HANS  STOVER                PHONE NO : 636 519 0268   
612 TRADE CENTER BLVD             SE DECISION MADE: 21-JUN-13
CHESTERFIELD MO 63005             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYRDROMAX HMEF
A-M SYSTEMS                       510(k) NO: K130664(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DR.                SE DECISION MADE: 21-JUN-13
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
ENCORE MEDICAL, L.P.              510(k) NO: K130099(SPECIAL)
ATTN: WILLIAM  GARZON             PHONE NO : 512 834 6391   
9800 METRIC BLVD.                 SE DECISION MADE: 21-JUN-13
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K130833(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN           PHONE NO : 949 706 7456   
55 NORTHERN BLVD., SUITE 200      SE DECISION MADE: 21-JUN-13
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERTAIN BELLATEK PROVISIONAL ABUTMENTS
BIOMET 3I                         510(k) NO: K130310(TRADITIONAL)
ATTN: JACQUELYN A HUGHES, RAC     PHONE NO : 561 776 6840   
4555 RIVERSIDE DR.                SE DECISION MADE: 21-JUN-13
Palm Bch Gdns FL 33410            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROTEUS PATCH INCLUDING INGESTIBLE SENSOR
PROTEUS DIGITAL HEALTH, INC.      510(k) NO: K131524(SPECIAL)
ATTN: ZAHEDEH  HATAMKHANY         PHONE NO : 650 637 6109   
2600 BRIDGE PARKWAY, SUITE 101    SE DECISION MADE: 23-JUN-13
REDWOOD CITY CA 94065             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOSLEEVE
RIJUVEN CORP                      510(k) NO: K131287(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 888 729 9674   
1468 HARWELL AVE.                 SE DECISION MADE: 24-JUN-13
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STEALTH 360 ORBITAL PAD SYSTEM
CARDIO SYSTEMS, INC.              510(k) NO: K131092(SPECIAL)
ATTN: MAUREEN  MCDONNELL          PHONE NO : 651 259 1644   
651 CAMPUS DRIVE                  SE DECISION MADE: 24-JUN-13
SAINT PAUL MN 55112 3495          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LAWMAX DILATOR
LIFETECH SCIENTIFIC (SHENZHEN) CO.510(k) NO: K123842(TRADITIONAL)
ATTN: LILY  SHI                   PHONE NO : 86 755860 26416
LANGSHAN 2ND STREET NANSHAN DISTRISE DECISION MADE: 24-JUN-13
SHENZHENG, GUANGDONG    CH 518057 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHANGRING
WUHU SNNDA MEDICAL TREATMENT APPLI510(k) NO: K131373(SPECIAL)
ATTN: BO  GONG                    PHONE NO : 86 21 64957283
503 ROOM, 8 BUILDING, 600 LIU ZHOUSE DECISION MADE: 25-JUN-13
SHANGHAI    CH 200233             510(k) STATEMENT

DEVICE: DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING
I.T.S. GMBH                       510(k) NO: K130008(TRADITIONAL)
ATTN: AL  LIPPINCOTT              PHONE NO : 952 492 5858   
3150 E. 200TH STREET              SE DECISION MADE: 25-JUN-13
PRIOR LAKE MN 55372               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM ("EPI MINI")
EPI MOBILE HEALTH SOLUTIONS (S) PT510(k) NO: K121628(TRADITIONAL)
ATTN: KARL M NOBERT               PHONE NO : 202 626 6630   
1200 19TH STREET, NW              SE DECISION MADE: 25-JUN-13
WASHINGTON DC 20032               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE
PYNG MEDICAL CORP.                510(k) NO: K130487(TRADITIONAL)
ATTN: MICHELE  TYLER              PHONE NO : 604 303796 4
13480 CRESTWOOD PLACE UNIT 210    SE DECISION MADE: 25-JUN-13
RICHMOND, BC    CA V6V 2J9        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFINI RADIOFREQUENCY SYSTEM
LUTRONIC CORPORATION              510(k) NO: K121481(TRADITIONAL)
ATTN: JHUNG  WON VOJIR            PHONE NO : 215 205 2219   
6 NESHAMINY INTERPLEX, SUITE 207  SE DECISION MADE: 25-JUN-13
TREVOSE PA 19053                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON
NEURO THERM, INC.                 510(k) NO: K122503(TRADITIONAL)
ATTN: F. DAVID  ROTHKOPF          PHONE NO : 508 231 8842   
200 HOMER AVE                     SE DECISION MADE: 25-JUN-13
ASHLAND MA 01721                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
SWISSRAY MEDICAL AG               510(k) NO: K131314(TRADITIONAL)
ATTN: TODD  SHOPP                 PHONE NO : 
TURBISTRASSE 25-27                SE DECISION MADE: 25-JUN-13
HOCHDORF, LU    SZ 6280           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EBA2 FEMORAL NAILING SYSTEM
CITIEFFE S.R.L.                   510(k) NO: K131005(SPECIAL)
ATTN: CLAUDE  BERTHION            PHONE NO : 386 672 2630   
110 E. GRANADA BLVD SUITE 209     SE DECISION MADE: 25-JUN-13
ORMOND BEACH FL 32176             510(k) STATEMENT

DEVICE: TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION
TRACTUS CORPORATION               510(k) NO: K131489(TRADITIONAL)
ATTN: MARK  JOB                   PHONE NO : 763 682 4139   
1394 25TH ST. NW                  SE DECISION MADE: 25-JUN-13
BUFFALO MN 55313                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: KSEA BIPOLAR ELECTRODE
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K122983(TRADITIONAL)
ATTN: WINKIE  WONG                PHONE NO : 424 218 8379   
2151 E. GRAND AVE.                SE DECISION MADE: 26-JUN-13
EL SEGUNDO CA 90245               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMOCONCENTRATOR
MAQUET CARDIOPULMONARY AG         510(k) NO: K123288(TRADITIONAL)
ATTN: INGRID  RICHTER             PHONE NO : 011 497222 9320
KEHLER STRASSE 31                 SE DECISION MADE: 26-JUN-13
RASTATT    GM 76437               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONITOR B40
GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K130584(TRADITIONAL)
ATTN: CASARSA  ROBERT             PHONE NO : 414 362 3063   
8200 WEST TOWER AVE               SE DECISION MADE: 26-JUN-13
MILWAUKEE WI 53223                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 23GA CURVED ILLUMINATING LASER PROBE
PEREGRINE SURGICAL LTD.           510(k) NO: K122997(SPECIAL)
ATTN: RYAN  O'LEARY               PHONE NO : 215 348 0456   
51 BRITAIN DR.                    SE DECISION MADE: 26-JUN-13
NEW BRITAIN PA 18901              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR
CARL ZEISS MEDITEC INC            510(k) NO: K130549(TRADITIONAL)
ATTN: SARAH  HARRINGTON           PHONE NO : 925 560 5134   
5160 HACIENDA DR.                 SE DECISION MADE: 26-JUN-13
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
DIAZYME LABORATORIES              510(k) NO: K131556(SPECIAL)
ATTN: ABHIJIT  DATTA              PHONE NO : 858 455 4762   
12889 GREGG COURT                 SE DECISION MADE: 26-JUN-13
POWAY CA 92064                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LASERBRUSH
SUNETICS INTERNATIONAL MARKETING G510(k) NO: K121920(TRADITIONAL)
ATTN: JOHN  CARULLO               PHONE NO : 214 683 0724   
892 STEGER TOWNE RD  #44          SE DECISION MADE: 27-JUN-13
ROCKWALL TX 75032                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STREAMLINE TL SPINAL SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC  510(k) NO: K131100(TRADITIONAL)
ATTN: SARAH  MCINTYRE             PHONE NO : 906 225 5861   
375 RIVER PARK CIRCLE             SE DECISION MADE: 27-JUN-13
Marquette MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXLE INTERSPINOUS FUSION SYSTEM
X-SPINE SYSTEMS, INC.             510(k) NO: K130438(TRADITIONAL)
ATTN: DAVID  KIRSCHMAN, M.D.      PHONE NO : 937 847 8400   
452 ALEXANDERSVILLE RD.           SE DECISION MADE: 27-JUN-13
MIAMISBURG OH 45342               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LYRIC2
PHONAK LLC                        510(k) NO: K130790(TRADITIONAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 3638   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 27-JUN-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EARPROBE
PATH MEDICAL GMBH                 510(k) NO: K131141(TRADITIONAL)
ATTN: JOHANN  OSWALD              PHONE NO : 004 989 80076502
LANDSBERGER STR 63                SE DECISION MADE: 27-JUN-13
GERMERING, BAVARIA    GM D-82110  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER
SENORX, INC.                      510(k) NO: K131654(SPECIAL)
ATTN: SARAH  MCCARTNEY            PHONE NO : 480 638 2954   
1625 WEST 3RD STREET              SE DECISION MADE: 27-JUN-13
TEMPE AZ 85281                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KEELER SLIT LAMP H-SERIES
KEELER LTD.                       510(k) NO: K131589(ABBREVIATED)
ATTN: NICKIE  POWER               PHONE NO : 44 175382 7153
CLEWER HILL RD.                   SE DECISION MADE: 27-JUN-13
WINDSOR, BERKSHIRE    UK SL4 4AA  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)
DEPUY MITEK INC., A JOHNSON AND JO510(k) NO: K131683(SPECIAL)
ATTN: KRISTINE  CHRISTO           PHONE NO : 508 828 3359   
325 PARAMOUNT DRIVE               SE DECISION MADE: 27-JUN-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURECALL LABOR MONITOR
REPRODUCTIVE RESEARCH TECHNOLOGIES510(k) NO: K130002(TRADITIONAL)
ATTN: J. HARVEY  KNAUSS           PHONE NO : 832 675 9281   
1770 ST. JAMES, STE 600           SE DECISION MADE: 28-JUN-13
HOUSTON TX 77056 3433             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUDO PATH
LD TECHNOLOGY LLC                 510(k) NO: K131568(SPECIAL)
ATTN: ALBERT  MAAREK              PHONE NO : 305 379 9900   
100 N. BISCAYNE BLVD, STE 500     SE DECISION MADE: 28-JUN-13
MIAMI FL 33132                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIRVANA D PERSONAL LUBRICANT (TBD)
CHURCH & DWIGHT CO., INC.         510(k) NO: K123427(TRADITIONAL)
ATTN: EMILY  PEREZ                PHONE NO : 609 688 5347   
469 NORTH HARRISON STREET         SE DECISION MADE: 28-JUN-13
PRINCETON NJ 08543                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ET SMARTFIT ABUTMENT
HIOSSEN INC.                      510(k) NO: K123627(TRADITIONAL)
ATTN: PATRICK  LIM                PHONE NO : 888 678 0001   
85 BEN FAIRLESS DRIVE             SE DECISION MADE: 28-JUN-13
FAIRLESS HILLS PA 19030           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALLURACLARITY XPER FD SERIES X-RAY SYSTEM
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K130638(TRADITIONAL)
ATTN: KLIEN  VAN DAM              PHONE NO : 310 402795 225
VEENPLUIS 4-6                     SE DECISION MADE: 28-JUN-13
BEST    NT 5694 PC                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM
BIOTEST MEDICAL CORP.             510(k) NO: K123559(TRADITIONAL)
ATTN: FRED  LEE                   PHONE NO : 886 425326 668
NO.3-2, CHIEN-KUO ROAD, TEPZ TANTZSE DECISION MADE: 28-JUN-13
TAICHUNG    TW 42760              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVITIVE IX
ACTEGY LTD                        510(k) NO: K123354(TRADITIONAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 3638   
555 13TH STREET, NW               SE DECISION MADE: 28-JUN-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CODIAGNOSTIX IMPLANT PLANNING SOFTWARE
STRAUMANN USA                     510(k) NO: K130724(TRADITIONAL)
ATTN: ELAINE  ALAN                PHONE NO : 978 747 2513   
60 MINUTEMAN ROAD                 SE DECISION MADE: 28-JUN-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
SMITH & NEPHEW, INC.              510(k) NO: K123598(TRADITIONAL)
ATTN: BRADLEY  HEIL               PHONE NO : 901 339 6339   
7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 28-JUN-13
CORDOVA TN 38016                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS
STRAUMANN USA                     510(k) NO: K130808(SPECIAL)
ATTN: ELAINE  ALAN                PHONE NO : 978 747 2513   
60 MINUTEMAN ROAD                 SE DECISION MADE: 28-JUN-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CODA BALLOON CATHETER
COOK, INC.                        510(k) NO: K122917(SPECIAL)
ATTN: ELYSIA  EASTON              PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 28-JUN-13
Blmgtn IN 47404                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOE FLUID STATUS MONITOR
NONINVASIVE MEDICAL TECHNOLOGIES, 510(k) NO: K131509(SPECIAL)
ATTN: MARC  O'GRIOFA              PHONE NO : 702 614 3360   
6412 S. ARVILLE STREET            SE DECISION MADE: 28-JUN-13
LAS VEGAS NV 89118                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUICKVUE INFLUENZA A+B
QUIDEL CORP.                      510(k) NO: K131619(SPECIAL)
ATTN: JOHN D TAMERIUS             PHONE NO : 858 552 7908   
10165 MCKELLAR CT.                SE DECISION MADE: 28-JUN-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES
KIMBERLY-CLARK CORPORATION        510(k) NO: K122653(TRADITIONAL)
ATTN: DAVID  LEE                  PHONE NO : 770 587 7167   
1400 HOLCOMB BRIDGE RD. BLDG 300/1SE DECISION MADE: 26-JUN-13
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK
INTUITIVE SURGICAL, INC.          510(k) NO: K130726(SPECIAL)
ATTN: MELISSA S GONZALEZ          PHONE NO : 408 523 8684   
1266 KIFER ROAD BUILDING 101      SE DECISION MADE: 07-JUN-13
SUNNYVALE CA 94086 5206           510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   211                                     
                                                 TOTAL WITH SUMMARIES        200                                     
                                                 TOTAL WITH STATEMENTS        11