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U.S. Department of Health and Human Services

Medical Devices

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May 2013 510(k) Clearances

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


DEVICE: SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM
BIOTEST MEDICAL CORP.             510(k) NO: K122525(SPECIAL)
ATTN: AMANDA  CHIANG              PHONE NO : 886 4 25326668
NO.3-2, CHIEN-KUO ROAD, TEPZ TANTZSE DECISION MADE: 02-MAY-13
TAICHUNG    TW 427                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K130870(TRADITIONAL)
ATTN: ERIKA  AMMIRATI             PHONE NO : 650 949 2768   
575 SHIRLYNN COURT                SE DECISION MADE: 02-MAY-13
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K123953(TRADITIONAL)
ATTN: HYMAN  KATZ PH.D.           PHONE NO : 973 852 0158   
4 HENDERSON DRIVE                 SE DECISION MADE: 02-MAY-13
WEST CALDWELL NJ 07006            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE
PSYCHEMEDICS CORP.                510(k) NO: K130811(TRADITIONAL)
ATTN: VIRGINIA  HILL              PHONE NO : 310 216 7776   
5832 UPLANDER WAY                 SE DECISION MADE: 02-MAY-13
CULVER CITY CA 90230              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE
TIANJIN NEW BAY BIORESEARCH CO., L510(k) NO: K122064(TRADITIONAL)
ATTN: ROGER  DE BOCK              PHONE NO : 619 453 0930   
4455 MURPHY CANYON RD SUITE 204   SE DECISION MADE: 07-MAY-13
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTA FLASH ENA7
INOVA DIAGNOSTICS, INC.           510(k) NO: K122923(TRADITIONAL)
ATTN: MICHAEL  MAHLER             PHONE NO : 858 586 9900   
9900 OLD GROVE RD.                SE DECISION MADE: 07-MAY-13
SAN DIEGO CA 92131 1638           510(k) STATEMENT

DEVICE: BD BACTEC LYTIC/10 ANAEROBIC/F (PLASTIC)
BECTON DICKINSON & CO.            510(k) NO: K123903(TRADITIONAL)
ATTN: PAUL  SWIFT                 PHONE NO : 410 316 4905   
7 LOVETON CIR., MC 614            SE DECISION MADE: 13-MAY-13
SPARKS MD 21152                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UCP HOME DRUG SCREENING TEST; CARDS, CUPS
UCP BIOSCIENCES, INC.             510(k) NO: K130463(TRADITIONAL)
ATTN: NANCY  CHEN                 PHONE NO : 408 392 0064   
1445 KOLL CIRCLE, STE. 111        SE DECISION MADE: 15-MAY-13
SAN JOSE CA 95112                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HUMAN IGM CSF KIT
THE BINDING SITE GROUP LTD        510(k) NO: K120750(TRADITIONAL)
ATTN: JILL  CONSTANTINE           PHONE NO : 440 121 4569500
8 CALTHORPE ROAD EDGBASTON        SE DECISION MADE: 17-MAY-13
BIRMINGHAM, WEST MIDLANDS    UK B1510(k) STATEMENT

DEVICE: HUMAN IGG CSF KIT
THE BINDING SITE GROUP LTD        510(k) NO: K120749(TRADITIONAL)
ATTN: JILL  CONSTANTINE           PHONE NO : 440 121 4569500
8 CALTHORPE ROAD EDGBASTON        SE DECISION MADE: 17-MAY-13
BIRMINGHAM, WEST MIDLANDS    UK B1510(k) STATEMENT

DEVICE: ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT
ALFA WASSERMANN DIAGNOSTICS TECHNO510(k) NO: K123322(TRADITIONAL)
ATTN: HYMAN  KATZ PH.D.           PHONE NO : 973 852 0158   
4 HENDERSON DRIVE                 SE DECISION MADE: 21-MAY-13
WEST CALDWELL NJ 07006            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K130551(TRADITIONAL)
ATTN: HYE-JOO  KIM, PHARM. D.     PHONE NO : 404 639 4643   
1600 CLIFTON RD., N.E. MAILSTOP C-SE DECISION MADE: 22-MAY-13
ATLANTA GA 30333                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE  AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
POLYMED THERAPEUTICS, INC         510(k) NO: K121065(TRADITIONAL)
ATTN: JJ  XIA                     PHONE NO : 301 250 0831   
12828 DOE LANE                    SE DECISION MADE: 24-MAY-13
GAITHERSBURG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREND PSA PLUS (REAGENT CARTRIDGE)
NANOEN TEK, INC.                  510(k) NO: K124056(TRADITIONAL)
ATTN: JUDITH E LOEBEL             PHONE NO : 203 881 1032   
1 JACK'S HILL RD. SUITE 1 (A&B)   SE DECISION MADE: 29-MAY-13
OXFORD CT 06478                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST,  AND HCG COMBO SERUM/URINE CASSETTE TEST
CHEMTRON BIOTECH, INC.            510(k) NO: K123844(TRADITIONAL)
ATTN: JANE  ZHANG                 PHONE NO : 858 530 2868   
8370 Juniper Creek Ln Ste 1-2     SE DECISION MADE: 30-MAY-13
San Diego CA 92126                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HUMAN IGA CSF KIT FOR USE ON SPAPLUS
THE BINDING SITE GROUP, LTD.      510(k) NO: K120901(TRADITIONAL)
ATTN: JILL  CONSTANTINE           PHONE NO : 440 121 4569500
8 CALTHORPE ROAD                  SE DECISION MADE: 30-MAY-13
EDGBASTON    UK B15 1QT           510(k) STATEMENT

DEVICE: WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K131232(TRADITIONAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 31-MAY-13
GAITHERSBURG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZYGAFIX SPINAL FACET SCREW SYSTEM
X-SPINE SYSTEMS, INC              510(k) NO: K123932(TRADITIONAL)
ATTN: DAVID  KIRSCHMAN            PHONE NO : 937 847 8400   
452 Alexandersville Rd            SE DECISION MADE: 01-MAY-13
Miamisburg OH 45342               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE
BIONESS, INC.                     510(k) NO: K123636(TRADITIONAL)
ATTN: KIM  TOMPKINS               PHONE NO : 661 362 5968   
25103 RYE CANYON LOOP             SE DECISION MADE: 01-MAY-13
VALENCIA CA 91355                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC
EXACTECH, INC.                    510(k) NO: K130434(TRADITIONAL)
ATTN: PATRICK  HUGHES             PHONE NO : 352 327 4762   
2320 N.W. 66TH CT.                SE DECISION MADE: 01-MAY-13
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K130626(SPECIAL)
ATTN: PHILIP  MALCA               PHONE NO : 
8200 WEST TOWER AVE.              SE DECISION MADE: 01-MAY-13
Milwaukee WI 53223                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K130169(TRADITIONAL)
ATTN: SUSAN  KAGAN                PHONE NO : 508 880 8097   
325 PARAMOUNT DR.                 SE DECISION MADE: 01-MAY-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATLANTIS STRAUMANN BONE LEVEL ABUTMENT
DENTSPLY IMPLANT                  510(k) NO: K130216(TRADITIONAL)
ATTN: LINDA K SCHULZ              PHONE NO : 858 792 1235   
12264 EL CAMINO REAL SUITE 400    SE DECISION MADE: 01-MAY-13
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM
DERMAL LIFE LLC                   510(k) NO: K122595(TRADITIONAL)
ATTN: DIANE  HORWITZ, PH.D., RAC  PHONE NO : 703 307 2921   
2995 STEVEN MARTIN DR.            SE DECISION MADE: 01-MAY-13
FAIRFAX VA 22031                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TENDER TOUCH
SOMETECH CORPORATION              510(k) NO: K121401(TRADITIONAL)
ATTN: KI  HAN                     PHONE NO : 770 825 0100   
965 Oakland Rd. Suite 2B          SE DECISION MADE: 01-MAY-13
Lawrenceville GA 30044            510(k) STATEMENT

DEVICE: BIOLOX DELTA CERAMIC FEMORAL HEADS
ZIMMER GMBH                       510(k) NO: K130899(SPECIAL)
ATTN: REBECCA M BROOKS            PHONE NO : 574 371 8033   
P.O. BOX 708                      SE DECISION MADE: 01-MAY-13
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AGILIA INFUSION SYSTEM
FRESENIUS KABI AG                 510(k) NO: K121613(TRADITIONAL)
ATTN: CHERYL  ROSCHER             PHONE NO : 847 550 7909   
THREE CORPORATE DRIVE             SE DECISION MADE: 01-MAY-13
LAKE ZURICH IL 60047              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELISIO-H AND ELISIO-M HEMODIALYZERS
NIPRO MEDICAL CORPORATION         510(k) NO: K122347(TRADITIONAL)
ATTN: CAROLYN  GEORGE             PHONE NO : 678 947 3429   
6695 RIVER CREST PT               SE DECISION MADE: 01-MAY-13
SUWANEE GA 30024                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UTF STEM, REDUCED
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K123550(TRADITIONAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 357 73351X2212
NO 57, PARK AVE 2, SCIENCE PARK   SE DECISION MADE: 01-MAY-13
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
C.R. BARD, INC.                   510(k) NO: K130968(SPECIAL)
ATTN: KETI  SINO                  PHONE NO : 401 825 8575   
100 CROSSINGS BLVD.               SE DECISION MADE: 01-MAY-13
WARWICK RI 02886                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WATERLASE IPLUS ALL TISSUE LASER
BIOLASE TECHNOLOGY, INC.          510(k) NO: K122368(TRADITIONAL)
ATTN: EHAB  ESMAIL                PHONE NO : 901 431 3000   
4 CROMWELL                        SE DECISION MADE: 02-MAY-13
Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CYNOSURE 1064NM DIODE LASER
CYNOSURE, INC.                    510(k) NO: K123971(TRADITIONAL)
ATTN: IRINA  KULINETS             PHONE NO : 978 256 4200   
5 CARLISLE ROAD                   SE DECISION MADE: 02-MAY-13
WESTFORD MA 01886                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION
NATUS NEUROLOGY INCORPORATED      510(k) NO: K130346(SPECIAL)
ATTN: SHANE T SAWALL              PHONE NO : 608 829 8673   
1850 DEMING WAY                   SE DECISION MADE: 02-MAY-13
MIDDLETON WI 53562 0000           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUILION LB TRITON V4.91
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K123500(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DRIVE               SE DECISION MADE: 02-MAY-13
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY
BLACKROCK NEUROMED, LLC           510(k) NO: K122196(TRADITIONAL)
ATTN: JOHN  ZIOBRO                PHONE NO : 262 719 8922   
117 WEST SOUTH STREET             SE DECISION MADE: 02-MAY-13
OCONOMOWOC WI 53066               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INOMAX DSIR (DELIVERY SYSTEM)
INO THERAPEUTICS                  510(k) NO: K130605(SPECIAL)
ATTN: ROBERT  BOVY                PHONE NO : 608 226 3450   
2902 DAIRY DRIVE                  SE DECISION MADE: 02-MAY-13
MADISON WI 53718                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
SECA GMBH & CO. KG                510(k) NO: K122388(TRADITIONAL)
ATTN: SETH A MAILHOT              PHONE NO : 617 842 0484   
1300 I STREET, NW, 11TH FLOOR EASTSE DECISION MADE: 02-MAY-13
WASHINGTON DC 20005 3314          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM
GETINGE SOURCING LLC              510(k) NO: K120532(TRADITIONAL)
ATTN: BARB  SMITH                 PHONE NO : 585 214 6049   
1777 EAST HENRIETTA RD.           SE DECISION MADE: 02-MAY-13
ROCHESTER NY 14623 3133           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DVTCARE CA5
OSSUR AMERICAS INC                510(k) NO: K130174(TRADITIONAL)
ATTN: JOHN  LINDAHL               PHONE NO : 231 557 5349   
481 PETTIS AVE.                   SE DECISION MADE: 02-MAY-13
ADA MI 49301                      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER
GAMBRO RENAL PRODUCTS, INC.       510(k) NO: K130039(TRADITIONAL)
ATTN: KAE  MILLER                 PHONE NO : 303 222 6724   
14143 DENVER WEST PARKWAY SUITE 40SE DECISION MADE: 02-MAY-13
LAKEWOOD CO 80401                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KNOTLESS FIBERTAK SUTURE ANCHOR
ARTHREX, INC.                     510(k) NO: K130458(TRADITIONAL)
ATTN: CHRISTINA  FLORES           PHONE NO : 239 643 5553   
1370 Creekside Blvd               SE DECISION MADE: 03-MAY-13
Naples FL 34108                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIATHLON TRITANIUM TIBIAL BASEPLATE
STRYKER                           510(k) NO: K123486(TRADITIONAL)
ATTN: AUDREY  WITKO               PHONE NO : 201 831 6717   
325 CORPORATE DRIVE               SE DECISION MADE: 03-MAY-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVOIS PRO IMPLANT STSYEM
RIEMSER ARZNEIMITTEL AG           510(k) NO: K113539(TRADITIONAL)
ATTN: CHRISTOPH  WAHL             PHONE NO : 49 383 5176667
AN DER WIEK 7                     SE DECISION MADE: 03-MAY-13
GREIFSWALD-INSEL RIEMS    GM 17493510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AG GUFFILL
HOSPITECH RESPIRATION LTD.        510(k) NO: K122721(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 4 6388837
31 HAAVODA ST                     SE DECISION MADE: 03-MAY-13
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SLEEK OTW PTA CATHETER
C.R. BARD, INC.                   510(k) NO: K130786(SPECIAL)
ATTN: FIONA  NI MHULLAIN          PHONE NO : 353 53 9237111
MOYNE UPPER                       SE DECISION MADE: 03-MAY-13
ENNISCORTHY, CO. WEXFORD    EI EI 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QYAG LASER SYSTEM
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K130250(TRADITIONAL)
ATTN: NICOLE  BROWN               PHONE NO : 781 993 2442   
15 NETWORK DR                     SE DECISION MADE: 03-MAY-13
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KOMPREDA
CUSTOM SPINE, INC.                510(k) NO: K120597(TRADITIONAL)
ATTN: DAVID  BRUMFIELD            PHONE NO : 973 808 0019   
9 Campus Dr                       SE DECISION MADE: 03-MAY-13
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)
SMALL BONE INNOVATIONS, INC.      510(k) NO: K130147(SPECIAL)
ATTN: JOHN  MINIER                PHONE NO : 215 428 1791   
1380 S. PENNSYLVANIA AVE.         SE DECISION MADE: 03-MAY-13
MORRISVILLE PA 19067              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM
ONSET MEDICAL CORPORATION         510(k) NO: K121404(TRADITIONAL)
ATTN: JOSEPH  BISHOP              PHONE NO : 949 716 1100   
13900 ALTON PARKWAY, SUITE 120    SE DECISION MADE: 03-MAY-13
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER
MEDA CO. LTD.                     510(k) NO: K121243(TRADITIONAL)
ATTN: KAI  CHEN                   PHONE NO : 240 888 4001   
13505 BROADFIELD DR.              SE DECISION MADE: 03-MAY-13
POTOMAC MD 20854                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS
SMITH & NEPHEW, INC.              510(k) NO: K123159(TRADITIONAL)
ATTN: MARTIN  OSTMANN             PHONE NO : 901 399 1809   
1450 BROOKS RD.                   SE DECISION MADE: 03-MAY-13
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENSITE VELOCITY SYSTEM
ST. JUDE MEDICAL                  510(k) NO: K130594(TRADITIONAL)
ATTN: DONNA R LUNAK               PHONE NO : 651 756 2944   
ONE ST. JUDE MEDICAL DRIVE        SE DECISION MADE: 03-MAY-13
ST. PAUL MN 55117                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS
BIODENTA SWISS AG                 510(k) NO: K122559(TRADITIONAL)
ATTN: DAVID  EILER                PHONE NO : 417 174 71111
TRAMSTRASSE 16                    SE DECISION MADE: 03-MAY-13
BERNECK    SZ 9442                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEO PS KNEE SYSTEM
PIPELINE ORTHOPEDICS              510(k) NO: K122500(TRADITIONAL)
ATTN: TERRY  POWELL               PHONE NO : 703 562 9800   
901 KING STREET, SUITE 200        SE DECISION MADE: 03-MAY-13
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: METASURG NITINOL STAPLE IMPLANT
METASURG                          510(k) NO: K123926(TRADITIONAL)
ATTN: JOSHUA  SCOTT               PHONE NO : 281 398 5656   
SUITE 100                         SE DECISION MADE: 03-MAY-13
HOUSTON TX 77084                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL BLOOD PRESSURE MONITOR
LITTLE DOCTOR ELECTRONIC (NANTONG)510(k) NO: K123600(TRADITIONAL)
ATTN: SELINA  QIAN                PHONE NO : 860 513 80580022
NO. 8, TONGXING ROAD NANTONG ECONOSE DECISION MADE: 03-MAY-13
NANTONG, JIANGSU    CH 226009     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERISPINE PS PEDICLE SCREW
SAFE ORTHOPAEDICS                 510(k) NO: K130632(SPECIAL)
ATTN: PIERRE  DUMOUCHEL           PHONE NO : 330 134 215000
PARC DES BELLEVUES ALLEE R. LUXEMBSE DECISION MADE: 03-MAY-13
ERAGNY SUR OISE    FR 95610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTIGLASS L. O.R. GLASS SYRINGE
ARTIGLASS SRL                     510(k) NO: K122416(TRADITIONAL)
ATTN: FEDERICO  BACCARIN          PHONE NO : 390 495 290442
VIA PIEMONTE 13                   SE DECISION MADE: 03-MAY-13
DUE CARRARE PADOVA    IT 35020    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM)
STRYKER TRAUMA AG                 510(k) NO: K130334(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461   
325 CORPORATE DRIVE               SE DECISION MADE: 03-MAY-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM
TGM MEDICAL, INC.                 510(k) NO: K130084(TRADITIONAL)
ATTN: PRAKASH  PAI                PHONE NO : 916 358 8835   
5145 Golden Foothill Parkway SUITESE DECISION MADE: 03-MAY-13
El Dorado Hills CA 95762          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26
REPRO-MED SYSTEMS, INC. DBA RMS ME510(k) NO: K122404(TRADITIONAL)
ATTN: ANDREW I SEALFON            PHONE NO : 845 469 2042   
24 Carpenter Rd                   SE DECISION MADE: 06-MAY-13
CHESTER NY 10918                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMPI PHOENIX
DJO, LLC                          510(k) NO: K124016(ABBREVIATED)
ATTN: KEN  FISHER                 PHONE NO : 760 734 5599   
1430 DECISION STREET              SE DECISION MADE: 06-MAY-13
VISTA CA 92081                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE
ORTHO MEDICAL                     510(k) NO: K121702(TRADITIONAL)
ATTN: DAVID  ROTHKOPF             PHONE NO : 508 231 8842   
200 HOMER AVE.                    SE DECISION MADE: 06-MAY-13
ASHLAND MA 01721                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK
BIO-RAD LABORATORIES, INC.        510(k) NO: K130963(TRADITIONAL)
ATTN: SUZANNE  PARSONS            PHONE NO : 949 598 1467   
9500 JERONIMO RD.                 SE DECISION MADE: 06-MAY-13
IRVINE CA 92618 2017              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNITRON TINNITUS MASKER FEATURE
UNITRON HEARING                   510(k) NO: K130494(ABBREVIATED)
ATTN: JIM  REITER                 PHONE NO : 763 744 3300   
14755 27th Ave N                  SE DECISION MADE: 07-MAY-13
PLYMOUTH MN 55447                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AZURE ANTERIOR CERVICAL PLATE SYSTEM
ORTHOFIX, INC.                    510(k) NO: K130825(SPECIAL)
ATTN: ALLY  BADUEL                PHONE NO : 214 937 2000   
3451 PLANO PARKWAY                SE DECISION MADE: 07-MAY-13
LEWISVILLE TX 75056               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOVEROUND TEKNIQUE
HOVEROUND CORP.                   510(k) NO: K122741(TRADITIONAL)
ATTN: ROBERT  MUNCH               PHONE NO : 941 739 6200   
2151 WHITFIELD INDUSTRIAL WAY     SE DECISION MADE: 07-MAY-13
SARASOTA FL 34243                 510(k) STATEMENT

DEVICE: DILATOR TUBE SET
KOROS USA, INC.                   510(k) NO: K120590(TRADITIONAL)
ATTN: GABRIEL  KOROS              PHONE NO : 805 529 0825   
610 FLINN AVE.                    SE DECISION MADE: 07-MAY-13
MOORPARK CA 93021                 510(k) STATEMENT

DEVICE: TEPHAFLEX MELTBLOWN CONSTRUCT
TEPHA, INC.                       510(k) NO: K130326(TRADITIONAL)
ATTN: MARY P LEGRAW               PHONE NO : 781 357 1709   
99 HAYDEN, SUITE 360              SE DECISION MADE: 07-MAY-13
LEXINGTON MA 02421                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
HARTALEGA SDN BHD                 510(k) NO: K123368(TRADITIONAL)
ATTN: NURUL  AISYAH KONG          PHONE NO : 603 327 10178
NO. 7, KAWASAN PERUSAHAAN SURIA   SE DECISION MADE: 07-MAY-13
BESTARI JAYA SELANGOR    MY 45600 510(k) STATEMENT

DEVICE: ABL90 FLEX
RADIOMETER MEDICAL APS            510(k) NO: K123748(SPECIAL)
ATTN: SOREN  BOGESTRAND           PHONE NO : 45 38 273852
AKANDEVEJ 21                      SE DECISION MADE: 07-MAY-13
BRONSHOJ    DA DK-2700            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONI
GLOBALMED                         510(k) NO: K130624(TRADITIONAL)
ATTN: NICHOLAS  CAMPBELL          PHONE NO : 480 398 7430   
15020 N. 74TH ST.                 SE DECISION MADE: 07-MAY-13
SCOTTSDALE AZ 85260               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PUREFLUX-H HEMODIALYZER
NIPRO MEDICAL CORPORATION         510(k) NO: K122343(TRADITIONAL)
ATTN: CAROLYN  GEORGE             PHONE NO : 678 947 3429   
6695 RIVER CREST PT               SE DECISION MADE: 07-MAY-13
SUWANEE GA 30024                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOVERROUND TEKNIQUE
HOVEROUND CORP.                   510(k) NO: K122707(TRADITIONAL)
ATTN: ROBERT  MUNCH               PHONE NO : 941 739 6200   
2151 WHITFIELD INDUSTRIAL WAY     SE DECISION MADE: 07-MAY-13
SARASOTA FL 34243                 510(k) STATEMENT

DEVICE: PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)
PROTEUS DIGITAL HEALTH, INC.      510(k) NO: K131009(SPECIAL)
ATTN: JAFAR  SHENASA              PHONE NO : 650 637 6109   
2600 BRIDGE PARKWAY, SUITE 101    SE DECISION MADE: 07-MAY-13
REDWOOD CITY CA 94065             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEACON TISSUE MARKER
SCION MEDICAL TECHNOLOGIES LLC    510(k) NO: K130763(SPECIAL)
ATTN: JOSEPH  OSTENDORF           PHONE NO : 503 784 6756   
23879 BLUE SPRUCE RD              SE DECISION MADE: 08-MAY-13
SAUK CENTRE MN 56378              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDLINE BLOOD PRESSURE TRANSDUCER
MEDLINE INDUSTRIES, INC.          510(k) NO: K123095(ABBREVIATED)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   
ONE MEDLINE PLACE                 SE DECISION MADE: 08-MAY-13
MUNDELEIN IL 60060                510(k) STATEMENT

DEVICE: VOLISTA 400; VOLISTA 600
MAQUET SAS                        510(k) NO: K130513(SPECIAL)
ATTN: TOSIN  YEDESS               PHONE NO : 973 709 7376   
45 BARBOUR POND DRIVE             SE DECISION MADE: 08-MAY-13
WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OLYMPIC BRAINZ MONITOR
EXCEL-TECH LTD. (XLTEK)           510(k) NO: K123079(TRADITIONAL)
ATTN: DANIEL  RAMIREZ             PHONE NO : 905 829 5300 X 356
2568 BRISTOL CIR.                 SE DECISION MADE: 08-MAY-13
OAKVILLE, ONTARIO    CA L6H 5S1   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOL-CARE SAFETY NEEDLE
SOL-MILLENNIUM MEDICAL            510(k) NO: K123684(TRADITIONAL)
ATTN: JIM  BARLEY                 PHONE NO : 949 433 3058   
5415 Sugarloaf Pkwy Ste 2203      SE DECISION MADE: 08-MAY-13
Lawrenceville GA 30043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANGE SPINAL SYSTEM, SMALL STATURE
K2M, INC.                         510(k) NO: K122877(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR., S.E., SUITE F1    SE DECISION MADE: 08-MAY-13
Leesburg VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESPONSE SPINE SYSTEM
ORTHOPEDIATRICS, CORP.            510(k) NO: K130655(TRADITIONAL)
ATTN: MARK  FOX                   PHONE NO : 574 268 6379   
2850 FRONTIER DRIVE               SE DECISION MADE: 08-MAY-13
WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GRIDLOCK PLATING SYSTEM
TRILLIANT SURGICAL LTD            510(k) NO: K130964(SPECIAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 08-MAY-13
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
COVIDIEN                          510(k) NO: K130796(TRADITIONAL)
ATTN: KELSEY  LEE                 PHONE NO : 303 305 2760   
6135 GUNBARREL AVE.               SE DECISION MADE: 09-MAY-13
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANGE SPINAL SYSTEM
K2M, INC.                         510(k) NO: K131030(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR., S.E., SUITE F1    SE DECISION MADE: 09-MAY-13
Leesburg VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRA LAMINOPLASTY SYSTEM
SEASPINE, INC.                    510(k) NO: K130830(TRADITIONAL)
ATTN: JEFF  BRITTAN               PHONE NO : 760 727 8399   
2302 LA MIRADA DR.                SE DECISION MADE: 09-MAY-13
VISTA CA 92081 7862               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN
COVIDIEN, FORMERLY NELLCOR PURITAN510(k) NO: K123581(TRADITIONAL)
ATTN: MIA M WARE                  PHONE NO : 303 305 2750   
6135 Gunbarrel Ave                SE DECISION MADE: 09-MAY-13
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNITOX BOTOX SYRINGE
BIO-MED USA INC                   510(k) NO: K123710(TRADITIONAL)
ATTN: YOUNG  CHI                  PHONE NO : 973 278 5222   
111 ELLISON STREET                SE DECISION MADE: 09-MAY-13
PATERSON NJ 07505                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NMI PICC MAXIMAL BARRIER NURSING KITS
NAVILYST MEDICAL, INC.            510(k) NO: K131038(SPECIAL)
ATTN: MARION W GORDON             PHONE NO : 508 658 7942   
26 FOREST STREET                  SE DECISION MADE: 09-MAY-13
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
ZIMMER, INC.                      510(k) NO: K130661(TRADITIONAL)
ATTN: ANTHONY  FRANCALANCIA       PHONE NO : 574 372 4570   
P.O. BOX 708                      SE DECISION MADE: 09-MAY-13
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG
SAKURA SEIKI CO., LTD.            510(k) NO: K122774(TRADITIONAL)
ATTN: MARIA  GRIFFIN              PHONE NO : 704 843 1675
46-1, SHINDEN                     SE DECISION MADE: 09-MAY-13
CHIKUMA, NAGANO    JA 387-0018    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TEMPERATURE SENSOR CATHETER
DEGANIA SILICONE, LTD.            510(k) NO: K131020(SPECIAL)
ATTN: ZOYA  LEE                   PHONE NO : 972 467551 00
KIBBUTZ DEGANIA BET               SE DECISION MADE: 09-MAY-13
ISRAEL    IS 15130                510(k) STATEMENT

DEVICE: VARIANT(TM) II TURBO HBA1C KIT - 2.0
BIO-RAD LABORATORIES, INC., CLINIC510(k) NO: K130990(SPECIAL)
ATTN: EBONY  MCKINNIES            PHONE NO : 510 741 6265   
4000 Alfred Nobel Drive           SE DECISION MADE: 09-MAY-13
Hercules CA 94547                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAYSTATION
RAYSEARCH LABORATORIES AB         510(k) NO: K130617(TRADITIONAL)
ATTN: DAVID  HEDFORS              PHONE NO : 46 722 366110
SVEAVAGEN 25, PLAN 9              SE DECISION MADE: 10-MAY-13
STOCKHOLM    SW SE-111 34         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FINGERTIP PULSE OXIMETER
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K123871(SPECIAL)
ATTN: LEI  CHEN                   PHONE NO : 86 108879 8300
NORTH BUILDING 3F, NO.9 SHUANGYUANSE DECISION MADE: 10-MAY-13
SHIJINGSHAN DISTRICT, BEIJING    C510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZX-I POWER ADD ON
SPINERGY, INC.                    510(k) NO: K123769(TRADITIONAL)
ATTN: EDWARD A KROLL              PHONE NO : 440 546 9810   
5905 FAWN LANE                    SE DECISION MADE: 10-MAY-13
CLEVELAND OH 44141                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STINGRAY BIPOLAR FORCEPS
STINGRAY SURGICAL PRODUCTS        510(k) NO: K123478(SPECIAL)
ATTN: MARK  MCBRINN               PHONE NO : 561 210 7582   
156 NW 16th St                    SE DECISION MADE: 10-MAY-13
Boca Raton FL 33432               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SM TENS & PMS
HONG QIANGXING (SHEN ZHEN) ELECTRO510(k) NO: K121719(TRADITIONAL)
ATTN: DORIS  DONG                 PHONE NO : 862 131 261348
ROOM 1706, NO. 128 SONGLE RD SONGJSE DECISION MADE: 10-MAY-13
SHANGHAI    CH 201600             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYPERION X9
CEFLA S.C.                        510(k) NO: K123381(TRADITIONAL)
ATTN: BERTHOIN  CLAUDE            PHONE NO : 386 672 2630   
110 E. GRANADA BLVD. SUITE 207    SE DECISION MADE: 10-MAY-13
ORMOND BEACH FL 32176             510(k) STATEMENT

DEVICE: BOSTON KERATOPROSTHESIS OR BOSTON KPRO
MASSACHUSETTS EYE & EAR INFIRMARY 510(k) NO: K121203(TRADITIONAL)
ATTN: BRIAN J EDWARDS             PHONE NO : 508 643 0434   
49 PLAIN STREET                   SE DECISION MADE: 10-MAY-13
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
TOPCON CORP.                      510(k) NO: K130289(SPECIAL)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 10-MAY-13
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EUROTROL HEMATOCRIT CONTROL
EUROTROL B.V.                     510(k) NO: K121467(TRADITIONAL)
ATTN: PAUL B.P.  KOOIJMANS        PHONE NO : 313 186957 77
KEPLERLAAN 20                     SE DECISION MADE: 10-MAY-13
EDE    NL 6716 BS                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE
THE LAGADO CORP.                  510(k) NO: K120756(TRADITIONAL)
ATTN: ELLEN  BEUCLER              PHONE NO : 978 658 6888   
218 E. COMMERCIAL BLVD STE # 201-QSE DECISION MADE: 13-MAY-13
LAUDERDALE BY THE SEA FL 33308    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR
TORNIER, INC.                     510(k) NO: K122635(TRADITIONAL)
ATTN: LAEL J PICKETT              PHONE NO : 781 249 8030   
10801 NESBITT AVENUE              SE DECISION MADE: 13-MAY-13
BLOOMINGTON MN 55437              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AG MASS
HOSPITECH RESPIRATION LTD.        510(k) NO: K131099(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 4638 8837
31 HAAVODA ST                     SE DECISION MADE: 13-MAY-13
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CREO STABILIZATION SYSTEM
GLOBUS MEDICAL INC.               510(k) NO: K124058(TRADITIONAL)
ATTN: SARAH M FITZGERALD          PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 13-MAY-13
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMSE P-TLIF
INSTITUTE OF MUSCULOSKELETAL SCIEN510(k) NO: K130506(TRADITIONAL)
ATTN: JOHN  MORAN                 PHONE NO : 484 420 4219   
90 S. NEWTOWN STREET ROAD SUITE 10SE DECISION MADE: 13-MAY-13
NEWTOWN SQUARE PA 19073           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LATIS SPACER
GLOBUS MEDICAL INC.               510(k) NO: K123913(TRADITIONAL)
ATTN: CHRISTINA  KICHULA          PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 13-MAY-13
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QLAB QUANTIFICATION SOFTWARE HEART MODEL
PHILIPS HEALTHCARE                510(k) NO: K130159(TRADITIONAL)
ATTN: PENNY  GRECO                PHONE NO : 978 659 4615   
3000 MINUTEMAN RD                 SE DECISION MADE: 13-MAY-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES
LUCENXIA PRESCIENCE AG            510(k) NO: K123629(TRADITIONAL)
ATTN: ROBERT  HILL                PHONE NO : 41 417689 126
RATHAUSSTRASSE 7                  SE DECISION MADE: 13-MAY-13
BAAR    SZ 6341                   510(k) STATEMENT

DEVICE: REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT
REMINGTON MEDICAL, INC.           510(k) NO: K130282(TRADITIONAL)
ATTN: CAITLIN  SENTER, MS, RAC    PHONE NO : 770 888 8520   
6830 MEADOWRIDGE CT.              SE DECISION MADE: 13-MAY-13
ALPHARETTA GA 30005               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M)
MICROLIFE CORP.                   510(k) NO: K122013(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 949 706 7456   
55 NORTHERN BLVD. SUITE 200       SE DECISION MADE: 13-MAY-13
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYDROSIL; MAGIC; PERSONAL CATHETER
ROCHESTER MEDICAL CORP.           510(k) NO: K122785(TRADITIONAL)
ATTN: ROB  ANGLIN                 PHONE NO : 507 533 9613   
ONE ROCHESTER MEDICAL DR.         SE DECISION MADE: 14-MAY-13
STEWARTVILLE MN 55976             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
DORNIER MEDTECH SYSTEMS           510(k) NO: K130729(SPECIAL)
ATTN: JOHN  HOFFER                PHONE NO : 770 514 6163   
1155 ROBERTS BLVD                 SE DECISION MADE: 14-MAY-13
KENNESAW GA 30144                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100
SENSUS HEALTHCARE                 510(k) NO: K123985(TRADITIONAL)
ATTN: KAL  FISHMAN                PHONE NO : 561 922 5808   
851 BROKEN SOUND PKWY NW #215     SE DECISION MADE: 14-MAY-13
BOCA RATON FL 33487               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATRICLIP GILLINOV-COSGROVE LAA CLIP
ATRICURE, INC.                    510(k) NO: K131107(SPECIAL)
ATTN: REBECCA  WALTERS            PHONE NO : 513 755 4576   
6217 CENTRE PARK DRIVE            SE DECISION MADE: 14-MAY-13
WEST CHESTER OH 45069             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPEED SHIFT
BIOMEDICAL ENTERPRISES, INC       510(k) NO: K124022(TRADITIONAL)
ATTN: JOE  SOWARD                 PHONE NO : 210 677 0354   
14785 OMICRON DR STE 205          SE DECISION MADE: 14-MAY-13
SAN ANTONIO TX 78245              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASCULAR CLAMPS
HEBU MEDICAL GMBH                 510(k) NO: K123077(TRADITIONAL)
ATTN: ANGELIKA  SCHERP            PHONE NO : 011 312061 25626
AMSTEL 320-1                      SE DECISION MADE: 14-MAY-13
AMSTERDAM    NL 1017 AP           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET
SPENCER FILLMORE                  510(k) NO: K123912(TRADITIONAL)
ATTN: CHRISTINA  BERNSTEIN        PHONE NO : 514 450 0515   
2670 LEAVENWORTH ST.              SE DECISION MADE: 14-MAY-13
SAN FRANCISCO CA 94133            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ILIZAROV DRILL TIP WIRES
SMITH & NEPHEW, INC.              510(k) NO: K130479(TRADITIONAL)
ATTN: DAVID  HENLEY               PHONE NO : 901 399 6487   
1450 BROOKS RD.                   SE DECISION MADE: 14-MAY-13
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ITCLAMP 50
INNOVATIVE TRAUMA CARE INC        510(k) NO: K123551(TRADITIONAL)
ATTN: RICHARD  WAITE              PHONE NO : 210 582 5850   
3463 MAGIC DR. SUITE 120          SE DECISION MADE: 14-MAY-13
SAN ANTONIO TX 78229              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
TOPCON MEDICAL LASER SYSTEMS, INC 510(k) NO: K123542(TRADITIONAL)
ATTN: PAMELA M BUCKMAN            PHONE NO : 925 980 7007   
2800 PLEASANT HILL RD., SUITE 175 SE DECISION MADE: 15-MAY-13
PLEASANT HILL CA 94553            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
ORTHO-CLINICAL DIAGNOSTICS, INC.  510(k) NO: K123930(TRADITIONAL)
ATTN: MICHAEL M BYRNE             PHONE NO : 585 453 3143   
100 INDIGO CREEK DR.              SE DECISION MADE: 15-MAY-13
ROCHESTER NY 14626 5101           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NBX - NON BRIDGING EXTERNAL FIXATOR HAND
NUTEK ORTHOPAEDICS, INC.          510(k) NO: K122777(TRADITIONAL)
ATTN: PETER  MINCIELI             PHONE NO : 954 779 1400   
301 S.W. 7TH ST.                  SE DECISION MADE: 15-MAY-13
FT. LAUDERDALE FL 33315           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3F PRO-PICC
MEDICAL COMPONENTS INC            510(k) NO: K123617(TRADITIONAL)
ATTN: JESSICA  LEO                PHONE NO : 215 256 4201   
1499 DELP DRIVE                   SE DECISION MADE: 15-MAY-13
HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYRA CREATININE REAGENT
MEDICA CORPORATION                510(k) NO: K123586(SPECIAL)
ATTN: PHOTIOS  MAKRIS             PHONE NO : 781 275 4892   
5 OAK PARK DRIVE                  SE DECISION MADE: 15-MAY-13
BEDFORD MA 01730                  510(k) STATEMENT

DEVICE: GENESISPLUS
CUTERA, INC.                      510(k) NO: K122493(TRADITIONAL)
ATTN: CONNIE  HOY                 PHONE NO : 415 657 5592   
3240 BAYSHORE BLVD                SE DECISION MADE: 15-MAY-13
BRISBANE CA 94005                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT
C.R. BARD, INC.                   510(k) NO: K130366(TRADITIONAL)
ATTN: JONI  CREAL                 PHONE NO : 480 638 2906   
1625 WEST 3RD ST.                 SE DECISION MADE: 15-MAY-13
TEMPE AZ 85281                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAUFLON MULTIPURPOSE SOLUTION
SAUFLON PHARMACEUTICALS, LTD.     510(k) NO: K130734(TRADITIONAL)
ATTN: CHRISTOPHER  SMEJKAL        PHONE NO : 440 208 3224200
49-53 YORK ST.                    SE DECISION MADE: 15-MAY-13
TWICKENHAM, MIDDLESEX    UK TW1-3L510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WRIST AUTOMATIC BLOOD PRESSURE MONITOR
LITTLE DOCTOR ELECTRONIC (NANTONG)510(k) NO: K123800(TRADITIONAL)
ATTN: SELINA  QIAN                PHONE NO : 86 513805 80022
No. 8, Tongxing Road, Nantong EconSE DECISION MADE: 15-MAY-13
Nantong    CN 226007              510(k) STATEMENT

DEVICE: ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE
ALERE SAN DIEGO INC. DBA BIOSITE,I510(k) NO: K120615(TRADITIONAL)
ATTN: EDWARD  BREHM, PH.D.        PHONE NO : 858 805 3071   
9975 SUMMERS RIDGE RD             SE DECISION MADE: 15-MAY-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K122644(SPECIAL)
ATTN: PATRICIA D JONES            PHONE NO : 610 448 3536   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 16-MAY-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PORTABLE X-RAY SYSTEM
OSSTEM IMPLANT CO.,LTD            510(k) NO: K122124(TRADITIONAL)
ATTN: PATRICK  LIM                PHONE NO : 888 678 0001   
85 BEN FAIRLESS DR.               SE DECISION MADE: 16-MAY-13
FAIRLESS HILLS PA 19030           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER
MAQUET CARDIOPULMONARY AG         510(k) NO: K130639(SPECIAL)
ATTN: KATRIN  SCHWENKGLENKS       PHONE NO : 011 497475 9210
KEHLER STRASSE 31                 SE DECISION MADE: 16-MAY-13
RASTATT    GM 76437               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K124040(TRADITIONAL)
ATTN: PINJUNG  CHEN               PHONE NO : 886 266258 818 #1176
6F NO.127, WUGONG 2ND RD., WUGU DISE DECISION MADE: 16-MAY-13
NEW TAIPEI CITY    TW 241         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AEROBIKA  POSITIVE EXPIRATORY PRESSURE DEVICE
TRUDELL MEDICAL INTL.             510(k) NO: K123400(TRADITIONAL)
ATTN: DARRYL  FISCHER             PHONE NO : 519 455 7060   
725 THIRD ST.                     SE DECISION MADE: 16-MAY-13
LONDON    CA N5V 5G4              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRUXZIR SHADED
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K130924(SPECIAL)
ATTN: ARMIN  ZEHTABCHI            PHONE NO : 949 225 1234   
2212 DUPONT DR., SUITE JJK        SE DECISION MADE: 16-MAY-13
IRVINE CA 92612                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GATEWAY ADVANAGE Y-ADAPTER
BOSTON SCIENTIFIC CORP.           510(k) NO: K130909(TRADITIONAL)
ATTN: CHRISTINE  SHOEMAKER        PHONE NO : 508 683 4214   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 16-MAY-13
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VINTAGE MP PRESS OVER
SHOFU DENTAL CORPORATION          510(k) NO: K122614(TRADITIONAL)
ATTN: DAVID P MORAIS              PHONE NO : 760 736 3277   
1225 STONE DRIVE                  SE DECISION MADE: 16-MAY-13
SAN MARCOS CA 92078               510(k) STATEMENT

DEVICE: CRYSTALSERT DELIVERY SYSTEM
BAUSCH & LOMB                     510(k) NO: K123736(TRADITIONAL)
ATTN: JASON  SMITH                PHONE NO : 800 393 6642   
30 ENTERPRISE SUITE 450           SE DECISION MADE: 16-MAY-13
ALISO VIEJO CA 92656 7115         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE
SURGICAL SPECIALTIES CORP. DBA ANG510(k) NO: K131224(SPECIAL)
ATTN: KRISTEN  STOWELL            PHONE NO : 610 404 3367   
100 DENNIS DR.                    SE DECISION MADE: 16-MAY-13
Reading PA 19606                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4D VIEW
GE HEALTHCARE                     510(k) NO: K131118(SPECIAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 INNOVATION DRIVE             SE DECISION MADE: 16-MAY-13
WAUWATOSA WI 53233                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOBILECT VIEWER
NEPHOSITY, INC.                   510(k) NO: K123082(TRADITIONAL)
ATTN: MICHAEL  PAN                PHONE NO : 650 429 8917   
615 GRANT AVENUE 3F               SE DECISION MADE: 16-MAY-13
SAN FRANCISCO CA 94108            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGNETOM SKYRA
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123510(TRADITIONAL)
ATTN: NADIA  SOOKDEO              PHONE NO : 610 448 4918   
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 17-MAY-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOMNODENT HERBST; CLASSIC, FLEX
SOMNOMED INC.                     510(k) NO: K130558(SPECIAL)
ATTN: KATHRYN A JAYNE             PHONE NO : 888 447 6673   
7460 Warren Pkwy Ste 190          SE DECISION MADE: 17-MAY-13
Frisco TX 75034                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIO HD OTOSCOPE
BLUE FOCUS                        510(k) NO: K123821(TRADITIONAL)
ATTN: KI CHEOL  HAN               PHONE NO : 770 825 0100   
965 OAKLAND RD SUITE 2B           SE DECISION MADE: 17-MAY-13
LAWRENCEVILLE GA 30044            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML
HERAEUS KULZER, LLC               510(k) NO: K130647(TRADITIONAL)
ATTN: JAMIE  MEARNA               PHONE NO : 574 299 5421   
300 Heraeus Way                   SE DECISION MADE: 17-MAY-13
SOUTH BEND IN 46614               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ERCHONIA VERJU LASER SYSTEM WITH MASSAGER
ERCHONIA MEDICAL, INC.            510(k) NO: K130922(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
33 GOLDEN EAGLE LANE              SE DECISION MADE: 17-MAY-13
LITTLETON CO 80127                510(k) STATEMENT

DEVICE: THE VAULT SYSTEM
SOMERSAULT ORTHOPEDICS, INC.      510(k) NO: K124051(TRADITIONAL)
ATTN: PAMELA M BUCKMAN            PHONE NO : 925 980 7007   
2800 PLEASANT HILL ROAD, SUITE 175SE DECISION MADE: 17-MAY-13
PLEASANT HILL CA 94523            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE
AESCULAP, INC.                    510(k) NO: K121976(TRADITIONAL)
ATTN: KATHY A RACOSKY             PHONE NO : 610 984 9291   
3773 CORPORATE PARKWAY            SE DECISION MADE: 17-MAY-13
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROQ 3.6
SYNTERMED, INC.                   510(k) NO: K130451(TRADITIONAL)
ATTN: KENNETH  VAN TRAIN          PHONE NO : 888 263 4446   
245 SOUTH OWENS DRIVE             SE DECISION MADE: 17-MAY-13
ANAHEIM CA 92808                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SCOPEVALET DISPOSABLE BIOPSY VALVE
THE RUHOF CORP.                   510(k) NO: K122417(TRADITIONAL)
ATTN: KIMBERLY  MCCOY             PHONE NO : 254 251 7155   
611 WEST 5TH STREET THIRD FLOOR   SE DECISION MADE: 17-MAY-13
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEODENT IMPLANT SYSTEM
JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K123022(TRADITIONAL)
ATTN: ALLISON C KOMIYAMA          PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 17-MAY-13
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
TORNIER SAS                       510(k) NO: K130533(SPECIAL)
ATTN: SEVERINE  BONNETON          PHONE NO : 003 347661 3500
161 RUE LAVOISIER                 SE DECISION MADE: 17-MAY-13
MONTBONNOT SAINT MARTIN    FR 3833510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K130885(TRADITIONAL)
ATTN: CHRISTINE  DUNBAR           PHONE NO : 925 293 5442   
757 A ARNOLD DRIVE                SE DECISION MADE: 17-MAY-13
MARTINEZ CA 94553                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME
GE HEALTHCARE SURGERY GE OEC MEDIC510(k) NO: K123603(TRADITIONAL)
ATTN: GERALD  BUSS                PHONE NO : 801 517 6591   
384 WRIGHT BROTHERS DRIVE         SE DECISION MADE: 17-MAY-13
SALT LAKE CITY UT 84116           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)
COTRONIC TECHNOLOGY LIMITED       510(k) NO: K120671(TRADITIONAL)
ATTN: TANI  MOK                   PHONE NO : 852 260 22021
WEST OF ZHOU SHI RD XI XIANG ST,  SE DECISION MADE: 17-MAY-13
SHEN ZHEN, GUANG DONG    CH 518126510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRYOUT-VPS HOLDING PASTE
CROWN DELTA CORP.                 510(k) NO: K122974(TRADITIONAL)
ATTN: MARK  KONOPKA               PHONE NO : 914 245 8910   
1550 FRONT ST.                    SE DECISION MADE: 17-MAY-13
YORKTOWN HEIGHTS NY 10598         510(k) STATEMENT

DEVICE: BREATHE CPAP SYSTEM
BREATHING TECHNOLOGIES            510(k) NO: K130037(TRADITIONAL)
ATTN: CRAIG  COOMBS               PHONE NO : 650 380 2474   
1193 SHERMAN ST                   SE DECISION MADE: 17-MAY-13
IRVINE CA 94501                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MECTALIF ANTERIOR STAND-ALONE
MEDACTA INTERNATIONAL             510(k) NO: K124034(TRADITIONAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 437 7085   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 17-MAY-13
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K130105(TRADITIONAL)
ATTN: JULIE  VAFIDES              PHONE NO : 508 977 6645   
325 PARAMOUNT DR.                 SE DECISION MADE: 17-MAY-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
MEDICATECH USA                    510(k) NO: K130377(SPECIAL)
ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234 1735   
8870 RAVELLO COURT                SE DECISION MADE: 17-MAY-13
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM
SYNTHES (USA) LLC                 510(k) NO: K130146(TRADITIONAL)
ATTN: STACEY  BONNELL             PHONE NO : 610 719 5895   
1302 WRIGHTS LANE EAST            SE DECISION MADE: 20-MAY-13
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIROCAM CAPSULE ENDOSCOPE SYSTEM
INTROMEDIC CO., LTD               510(k) NO: K123428(TRADITIONAL)
ATTN: STEVE  KWON                 PHONE NO : 140 874 79876
STE 1104, E&C VENTURE DREAM TOWER SE DECISION MADE: 20-MAY-13
GURO-GU , SEOUL    KS 152-719     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NORDIC TUMOREX
NORDICNEUROLAB                    510(k) NO: K123306(TRADITIONAL)
ATTN: CHANDANA G BHANDARI         PHONE NO : 475 570709 5
MOLLENDALSVEIEN 65C               SE DECISION MADE: 20-MAY-13
BERGEN, HORDALAND    NO 5009      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P
ACME FILTER MASK INC.             510(k) NO: K123115(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 886 2 26789379
NO. 57 HU SHAN ROAD YINGGE DISTRICSE DECISION MADE: 20-MAY-13
NEW TAIPEI CITY    TW 23941       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL
RESONANCE INNOVATIONS LLC         510(k) NO: K130457(SPECIAL)
ATTN: RANDALL  JONES              PHONE NO : 402 934 2650   
9840 S. 140TH ST., STE 8          SE DECISION MADE: 20-MAY-13
OMAHA NE 68138                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM
INTAI TECHNOLOGY CORP.            510(k) NO: K122804(TRADITIONAL)
ATTN: KEVIN  WANG                 PHONE NO : 886 436 015336
9 JINGKE ROAD, NANTUN DISTRICT    SE DECISION MADE: 20-MAY-13
TAICHUNG CITY    TW 40852         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIGIS RX R PM/ AIGIS RX R ICD
TYRX , INC.                       510(k) NO: K130943(TRADITIONAL)
ATTN: SUSAN  OLINGER              PHONE NO : 732 964 1110   
1 DEER PARK DR. SUITE G           SE DECISION MADE: 20-MAY-13
MONMOUTH JUNCTION NJ 08852        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2
SORIN GROUP USA INC.              510(k) NO: K122735(TRADITIONAL)
ATTN: SCOTT  LIGHT                PHONE NO : 303 467 6313   
14401 WEST 65TH WAY               SE DECISION MADE: 21-MAY-13
ARVADA CO 80004                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)
NIHON KOHDEN CORP.                510(k) NO: K122214(TRADITIONAL)
ATTN: STEVE  GEERDES              PHONE NO : 949 580 1555   
90 ICON STREET                    SE DECISION MADE: 21-MAY-13
FOOTHILL RANCH CA 92610           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REMSTAR SE
RESPIRONICS, INC.                 510(k) NO: K130077(TRADITIONAL)
ATTN: FRANK  KADI                 PHONE NO : 724 387 4134   
1740 GOLDEN MILE HIGHWAY          SE DECISION MADE: 21-MAY-13
MONROEVILLE PA 15146              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
ROCHE DIAGNOSTICS                 510(k) NO: K123726(TRADITIONAL)
ATTN: DAVID  TRIBBETT             PHONE NO : 317 521 2964   
9115 HAGUE ROAD                   SE DECISION MADE: 21-MAY-13
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K131093(SPECIAL)
ATTN: RYAN  BORMANN               PHONE NO : 901 867 4409   
5677 AIRLINE RD.                  SE DECISION MADE: 21-MAY-13
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)
LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K130189(TRADITIONAL)
ATTN: LUBNA  SYED                 PHONE NO : 416 593 4323
439 UNIVERSITY AVE.               SE DECISION MADE: 21-MAY-13
TORONTO, ONTARIO    CA M5G 1Y8    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HUMICARE D900
GRUNDLER GMBH                     510(k) NO: K122705(TRADITIONAL)
ATTN: JIM  CASSI                  PHONE NO : 858 836 6081   
9001 SPECTRUM CENTER BLVD         SE DECISION MADE: 21-MAY-13
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM
DIO CORPORATION                   510(k) NO: K122519(TRADITIONAL)
ATTN: TIMOTHY  LEE                PHONE NO : 213 365 2875   
3540 WILSHIRE BLVD. SUITE 1104    SE DECISION MADE: 21-MAY-13
LOS ANGELES CA 90010              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM)
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K130539(TRADITIONAL)
ATTN: JULIE  VAFIDES              PHONE NO : 508 977 6645   
325 PARAMOUNT DR.                 SE DECISION MADE: 21-MAY-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLANAS POSTERIOR STABILIZATION SYSTEM
ALPHATEC SPINE, INC.              510(k) NO: K131119(SPECIAL)
ATTN: TREVOR  DENBO               PHONE NO : 760 494 6951   
5818 EL CAMINO REAL               SE DECISION MADE: 21-MAY-13
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K130842(TRADITIONAL)
ATTN: JOS  VAN VROONHOVEN         PHONE NO : 31 0 402794221
VEENPLUIS 4-6                     SE DECISION MADE: 21-MAY-13
BEST    NL 5684 PC                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ANYTHINK PACS WORKSTATION
BEIJING CREALIFE TECHNOLOGY CO., L510(k) NO: K131299(TRADITIONAL)
ATTN: WEIHUA  ZHOU                PHONE NO : 86 10 88288713
ROOM 519, HUITONG COMMERCE BUILDINSE DECISION MADE: 22-MAY-13
BEIJING    CH 100036              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM
JUSTRIGHT SURGICAL, LLC           510(k) NO: K123662(TRADITIONAL)
ATTN: MICHELE  LUCEY              PHONE NO : 603 763 3455   
128 BLYE HILL LANDING             SE DECISION MADE: 22-MAY-13
NEWBURY NH 03255                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARLE TISSUE ADHESIVE
ADVANCED MEDICAL SOLUTIONS (PLYMOU510(k) NO: K123133(TRADITIONAL)
ATTN: MICHAEL  BROWNE             PHONE NO : 441 752 209955
WESTERN WOOD WAY LANAGAGE SCIENCE SE DECISION MADE: 22-MAY-13
PLYMOUTH    UK PL7 5BG            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GETINGE 800HC- SERIES STEAM STERILIZER
GETINGE SOURCING LLC              510(k) NO: K122625(TRADITIONAL)
ATTN: BARB  SMITH                 PHONE NO : 585 214 6049   
1777 EAST HENRIETTA RD.           SE DECISION MADE: 22-MAY-13
ROCHESTER NY 14623 3133           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BREATHID HP SYSTEM
EXALENZ BIOSCIENCE LTD.           510(k) NO: K130524(TRADITIONAL)
ATTN: CLAY  ANSELMO               PHONE NO : 303 907 2955   
11925 W I-70 FRONTAGE RD NORTH SUISE DECISION MADE: 22-MAY-13
WHEAT RIDGE CO 80033              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WINX SLEEP THERAPY SYSTEM
APNICURE, INC.                    510(k) NO: K130538(SPECIAL)
ATTN: CHRIS  DANIEL               PHONE NO : 650 361 9300   
900 CHESAPEAKE DR                 SE DECISION MADE: 22-MAY-13
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UROMAX ULTRA BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K130804(TRADITIONAL)
ATTN: LAUREN  RUSSO               PHONE NO : 508 683 4707   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 22-MAY-13
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SANICLAVE 102, MODEL RS-SC-102
ALTERNATIVE PIONEERING RESEARCH AN510(k) NO: K122978(TRADITIONAL)
ATTN: ISAAC  ERICKSON             PHONE NO : 651 353 7806   
17319 LAKE BLVD.                  SE DECISION MADE: 23-MAY-13
SHAFER MN 55074                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISCOVERY MR750W 3.0T
GE MEDICAL SYSTEMS, LLC           510(k) NO: K130115(TRADITIONAL)
ATTN: MICHELLE  HUETTNER          PHONE NO : 262 521 6102   
3200 N. GRANDVIEW BLVD.           SE DECISION MADE: 23-MAY-13
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IVAS 10MM AND 15MM BALLOON CATHETER
STRYKER CORPORATION               510(k) NO: K130430(SPECIAL)
ATTN: CHRISTINA  MCKEE            PHONE NO : 269 389 4086   
4100 E. MILHAM AVE                SE DECISION MADE: 23-MAY-13
KALAMAZOO MI 49001                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATOM TRANSCAPSULE  V-707
ATOM MEDICAL CORPORATION          510(k) NO: K123937(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 23-MAY-13
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD
ELCAM MEDICAL A.C.A.L.            510(k) NO: K123084(TRADITIONAL)
ATTN: AHARON  COHEN               PHONE NO : 972 4 36988324
KIBBUTZ BAR-AM                    SE DECISION MADE: 23-MAY-13
D.N. MEROM HAGALIL    IS 13860    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIPELINE KNEE SYSTEM
PIPELINE ORTHOPEDICS              510(k) NO: K123692(TRADITIONAL)
ATTN: TERRY  POWELL               PHONE NO : 703 562 9800   
901 KING STREET, SUITE 200        SE DECISION MADE: 24-MAY-13
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES SYNCAGE EVOLUTION SPACER
SYNTHES (USA) PRODUCTS LLC        510(k) NO: K122639(TRADITIONAL)
ATTN: HEMAL  MEHTA                PHONE NO : 610 719 5424   
1230 Wilson Dr                    SE DECISION MADE: 24-MAY-13
West Chester PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK
CIRCADIANCE LLC                   510(k) NO: K130481(TRADITIONAL)
ATTN: RYAN T KASUN                PHONE NO : 724 327 0230   
3919 WILLIAM PENN HWY. SUITE 200  SE DECISION MADE: 24-MAY-13
MURRYSVILLE PA 15668              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM
CONFORMIS, INC.                   510(k) NO: K131019(SPECIAL)
ATTN: AMITA  SHAH                 PHONE NO : 781 345 9146   
28 Crosby Dr                      SE DECISION MADE: 24-MAY-13
Bedford MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
EV3 INC.                          510(k) NO: K130911(TRADITIONAL)
ATTN: LAURA J LIND                PHONE NO : 763 398 7000   
3033 CAMPUS DRIVE                 SE DECISION MADE: 24-MAY-13
PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: INTRABLOCK BIOBALL HIP SYSTEM (IBS)
MERETE MEDICAL GMBH               510(k) NO: K123619(TRADITIONAL)
ATTN: EMMANUEL  ANAPLIOTIS        PHONE NO : 49 30 779980114
102 ALT LANKWITZ                  SE DECISION MADE: 24-MAY-13
BERLIN    GM D-12247              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAY FRESH SKIN FOLD MANAGEMENT TEXTILE
QUICK-MED TECHNOLOGIES, INC.      510(k) NO: K121898(TRADITIONAL)
ATTN: MARY  MCNAMARA-CULLINANE    PHONE NO : 508 643 0434   
49 PLAIN STREET                   SE DECISION MADE: 24-MAY-13
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALIX ADVANCE KNOTLESS BR ANCHOR
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K130917(TRADITIONAL)
ATTN: YAYOI  FUJIMAKI             PHONE NO : 508 828 3541   
325 PARAMOUNT DR.                 SE DECISION MADE: 24-MAY-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TERASON USMART3200T ULTRASOUND SYSTEM
TERATECH CORP.                    510(k) NO: K131209(TRADITIONAL)
ATTN: BEN  CHIAMPA                PHONE NO : 781 270 4143   
77-79 TERRACE HALL AVE.           SE DECISION MADE: 24-MAY-13
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PROVIDENCE CERVICAL CAGE
PROVIDENCE MEDICAL TECHNOLOGY, INC510(k) NO: K122801(TRADITIONAL)
ATTN: EDWARD  LIOU                PHONE NO : 415 923 9376   
3650 MT Diablo Blvd Ste 104       SE DECISION MADE: 24-MAY-13
Lafayette CA 94549                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANTEGRADE FEMORAL NAIL
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K123569(TRADITIONAL)
ATTN: JULIE  GLENDRANGE           PHONE NO : 310 533 9966   
386 BEECH AVENUE UNIT B6          SE DECISION MADE: 24-MAY-13
TORRANCE CA 90501                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMES THERAPY DEVICE
AMES TECHNOLOGY, INC.             510(k) NO: K123746(TRADITIONAL)
ATTN: SHEILA  RAMERMAN, RAC       PHONE NO : 541 683 3017   
927 THRONE DRIVE                  SE DECISION MADE: 24-MAY-13
EUGENE OR 97402                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MTM CLEAR ALIGNER IN-OFFICE
DENTSPLY INTERNATIONAL, INC.      510(k) NO: K123925(TRADITIONAL)
ATTN: HELEN  LEWIS                PHONE NO : 717 849 4229   
221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 24-MAY-13
YORK PA 17405                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
SONOSCAPE COMPANY LIMITED         510(k) NO: K131088(TRADITIONAL)
ATTN: TOKI  WU                    PHONE NO : 86 755 26722850
4/F YIZHE BLDG, YUQUAN ROAD       SE DECISION MADE: 24-MAY-13
SHENZHEN, GUANGDONG    CH 518051  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LANX SPINAL FIXATION SYSTEM
LANX, INC.                        510(k) NO: K131156(SPECIAL)
ATTN: MICHAEL  MEDINA             PHONE NO : 303 443 7500   
310 INTERLOCKEN PARKWAY SUITE 120 SE DECISION MADE: 24-MAY-13
BROOMFIELD CO 80021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORONIS 3MP
BARCO N.V.                        510(k) NO: K131246(SPECIAL)
ATTN: LIEVEN DE  WANDEL           PHONE NO : 32 5623 3211
35 PRESIDENT KENNEDYPARK          SE DECISION MADE: 24-MAY-13
KORTRIJK    BE 8500               510(k) STATEMENT

DEVICE: WATER-FILLED TEETHER
SOLID TOY IND. LTD.               510(k) NO: K123855(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 24-MAY-13
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROFEMUR RENAISSANCE CLASSIC HIP STEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K130984(SPECIAL)
ATTN: YUAN  LI                    PHONE NO : 901 867 4146   
5677 AIRLINE RD.                  SE DECISION MADE: 24-MAY-13
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZENOLUX
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K130184(ABBREVIATED)
ATTN: GERHARD  POLZER             PHONE NO : 490 723137 05219
SCHWENNINGER STRASSE 13           SE DECISION MADE: 24-MAY-13
PFORZHEIM    GM 75179             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS
CORIN U.S.A.                      510(k) NO: K130343(TRADITIONAL)
ATTN: DIANA L MARTONE             PHONE NO : 813 977 4469   
5670 W CYPRESS STREET SUITE C     SE DECISION MADE: 28-MAY-13
TAMPA FL 33607                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
UNILENE S.A.C.                    510(k) NO: K123034(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
33 GOLDEN EAGLE LANE              SE DECISION MADE: 28-MAY-13
LITTLETON CO 80127                510(k) STATEMENT

DEVICE: FINGER PULSE OXIMETER
SHENZHEN KINGYIELD TECHNOLOGY CO.,510(k) NO: K123801(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 237-023                  SE DECISION MADE: 28-MAY-13
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIO COLOR 3MP LED
BARCO NV                          510(k) NO: K131295(SPECIAL)
ATTN: LIEVEN  DE WANDEL           PHONE NO : 32 56 233211
35 PRESIDENT KENNEDYPARK          SE DECISION MADE: 29-MAY-13
KORTRIJK    BE 8500               510(k) STATEMENT

DEVICE: ADROIT GUIDING CATHETER
CORDIS CORP., A JOHNSON & JOHNSON 510(k) NO: K131225(SPECIAL)
ATTN: MARY E HOLDEN               PHONE NO : 510 248 2961   
6500 PASEO PADRE PKWY.            SE DECISION MADE: 29-MAY-13
FREMONT CA 94555                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASOSTAT HEMOSTASIS DEVICE
FORGE MEDICAL INC.                510(k) NO: K123041(TRADITIONAL)
ATTN: MASON  DIAMOND              PHONE NO : 508 333 0108   
150 LEVINBERG LANE                SE DECISION MADE: 29-MAY-13
WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 740 SELECT
CAS MEDICAL SYSTEMS, INC.         510(k) NO: K130411(TRADITIONAL)
ATTN: RON  JEFFREY                PHONE NO : 203 488 6056   
44 EAST INDUSTRIAL RD.            SE DECISION MADE: 29-MAY-13
BRANFORD CT 06405                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ETIAM PACS COMPONENTS
ETIAM S.A.S.U.                    510(k) NO: K131392(TRADITIONAL)
ATTN: GERALDINE  TESSENS          PHONE NO : 33 2 99143386
2 RUE PIERRE JOSEPH COLIN         SE DECISION MADE: 29-MAY-13
RENNES    FR 35000                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SCANORA 3DX
PALODEX GROUP OY                  510(k) NO: K130297(SPECIAL)
ATTN: MATTI  TULIKOURA            PHONE NO : 358 10 2702000
NAHKELANTIE 160                   SE DECISION MADE: 29-MAY-13
TUUSULA    FI 04300               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
HEALTH & LIFE CO., LTD.           510(k) NO: K131121(SPECIAL)
ATTN: SARAH  SU                   PHONE NO : 866 282271 300 #1201
9F, NO.186, JIAN YI ROAD          SE DECISION MADE: 29-MAY-13
CHUNG HO CITY, TAIPEI    TW 235   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE
CARDIAC INSIGHT, INC.             510(k) NO: K130288(TRADITIONAL)
ATTN: DEBORAH  SHEFFIELD          PHONE NO : 206 853 6398   
5672 FLAGLER ROAD                 SE DECISION MADE: 29-MAY-13
NORDLAND WA 98358                 510(k) STATEMENT

DEVICE: EXSPIRON 1XI
RESPIRATORY MOTION, INC.          510(k) NO: K130170(SPECIAL)
ATTN: JENNY  FREEMAN, MD          PHONE NO : 781 373 1526   
411 WAVERLY OAKS ROAD BUILDING 1, SE DECISION MADE: 29-MAY-13
WALTHAM MA 02452                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MR PERMEABILITY
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K130278(TRADITIONAL)
ATTN: SUSAN  QUICK                PHONE NO : 440 483 2291   
595 MINER RD                      SE DECISION MADE: 29-MAY-13
CLEVELAND OH 44143                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
CARDIAC DESIGNS, LLC              510(k) NO: K131045(TRADITIONAL)
ATTN: RAYMOND J KELLY, IV         PHONE NO : 203 400 7566   
57 LAZY BROOK RD                  SE DECISION MADE: 29-MAY-13
MONROE CT 06468                   510(k) STATEMENT

DEVICE: MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
ENTRIGUE SURGICAL, INC.           510(k) NO: K130354(TRADITIONAL)
ATTN: GABRIELE G NIEDERAUER       PHONE NO : 210 298 6336   
12672 SILICON DR. STE 150         SE DECISION MADE: 29-MAY-13
SAN ANTONIO TX 78249              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORAMOIST
QUANTUM, INC.                     510(k) NO: K122663(TRADITIONAL)
ATTN: FRED  MA                    PHONE NO : 440 498 8199   
7195 LONGVIEW DRIVE               SE DECISION MADE: 30-MAY-13
CLEVELAND OH 44139                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT
BIODENTA SWISS AG                 510(k) NO: K123491(TRADITIONAL)
ATTN: DAVID  EILER                PHONE NO : 41 71 7471111
TRAMSTRASSE 16                    SE DECISION MADE: 30-MAY-13
BERNECK    SZ 9442                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
COOPERVISION, INC.                510(k) NO: K123202(SPECIAL)
ATTN: KARIN  GASTINEAU            PHONE NO : 925 621 3732   
6150 STONERIDGE MALL ROAD SUITE 37SE DECISION MADE: 30-MAY-13
PLEASANTON CA 94588               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEMORY PUMP MODEL Y4947
TOMY INTERNATIONAL                510(k) NO: K131027(TRADITIONAL)
ATTN: BRIAN  THOMAS               PHONE NO : 781 828 2824   
45 SHAWMUT ROAD                   SE DECISION MADE: 30-MAY-13
CANTON MA 02021                   510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: TRANSTEK BODY FAT ANALYZER
GUANGDONG TRANSTEK MEDICAL ELECTRO510(k) NO: K130311(TRADITIONAL)
ATTN: LEO  WANG                   PHONE NO : 086 288608 3300
NO.1 FANGHUA STREET, HI-TECH DISTRSE DECISION MADE: 30-MAY-13
CHENGDU    CH 610041              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALEUTIAN SPINAL SYSTEM
K2M, INC.                         510(k) NO: K130699(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DRIVE SE               SE DECISION MADE: 30-MAY-13
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAMPART O
SPINEOLOGY, INC.                  510(k) NO: K131216(SPECIAL)
ATTN: BRYAN  BECKER               PHONE NO : 651 256 8534   
7800 3RD ST N., SUITE 600         SE DECISION MADE: 30-MAY-13
ST. PAUL MN 55128                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IDRIVE ULTRA STERILIZATION TRAY
COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K130532(TRADITIONAL)
ATTN: KATHERINE  ROBERTSON        PHONE NO : 203 492 5299   
60 Middletown Ave                 SE DECISION MADE: 30-MAY-13
North Haven CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
BARD PERIPHERAL VASCULAR, INC.    510(k) NO: K131199(TRADITIONAL)
ATTN: MARIO  THOMAS               PHONE NO : 480 350 6014   
1625 WEST 3RD ST.                 SE DECISION MADE: 30-MAY-13
TEMPE AZ 85281                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FLASH AR PENTA / FLASH AR PENTA QUICK
3M DEUTSCHLAND GMBH               510(k) NO: K131404(TRADITIONAL)
ATTN: DESI W SOEGIARTO            PHONE NO : 49 8152 700
ESPE PLATZ, 82229                 SE DECISION MADE: 30-MAY-13
SEEFELD    GM GM                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE
RHYTHMLINK INTERNATIONAL, LLC     510(k) NO: K130287(TRADITIONAL)
ATTN: JAMES M MEWBORNE            PHONE NO : 803 252 1222   
1140 FIRST ST. SOUTH              SE DECISION MADE: 30-MAY-13
Columbia SC 29209                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAKE 1 ADVANCE
SYBRON DENTAL SPECIALTIES         510(k) NO: K130869(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 
1717 WEST COLLINS AVENUE          SE DECISION MADE: 30-MAY-13
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
CLINIQA CORPORATION               510(k) NO: K120900(TRADITIONAL)
ATTN: DAWN  GAST                  PHONE NO : 760 571 5255   
288 Distribution Street           SE DECISION MADE: 31-MAY-13
San Marcos CA 92078               510(k) STATEMENT

DEVICE: OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
BACTERIN INTERNATIONAL INC.       510(k) NO: K130498(TRADITIONAL)
ATTN: HOWARD L SCHRAYER           PHONE NO : 609 924 9510   
600 CRUISER LN.                   SE DECISION MADE: 31-MAY-13
BELGRADE MT 59714                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDLINE CANNULATED SCREW
MEDLINE INDUSTRIES, INC.          510(k) NO: K130319(TRADITIONAL)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   
ONE MEDLINE PLACE                 SE DECISION MADE: 31-MAY-13
MUNDELEIN IL 60060                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES
PROSBEN, INC.                     510(k) NO: K122700(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 866 3 5208829
11 F., NO. 58, SEC. 3 MINGCHAUN EASE DECISION MADE: 31-MAY-13
TAIPEI    TW 104                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARS SCREW; SLANT SCREW
ADVANCED INTERVENTIONAL TECHNOLOGY510(k) NO: K130954(TRADITIONAL)
ATTN: EDUARDO  MARCH              PHONE NO : 240 506 3212   
7000 CASHELL MANOR CT             SE DECISION MADE: 31-MAY-13
DERWOOD MD 20855                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRIDE UNICONDYLAR KNEE
BLUE BELT TECHNOLOGIES, INC.      510(k) NO: K123380(TRADITIONAL)
ATTN: RICK  CONFER                PHONE NO : 412 683 3844   
2828 LIBERTY AVENUE SUITE 100     SE DECISION MADE: 31-MAY-13
PITTSBURGH PA 15222               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERLIG
ANGELUS INDUSTRIA DE PRODUCTOS ODO510(k) NO: K123823(TRADITIONAL)
ATTN: LILIAN  LLULL               PHONE NO : 305 377 0077   
18851 NE 29TH AVE 720             SE DECISION MADE: 31-MAY-13
AVENTURA FL 33180                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGISEAL TOPICAL SKIN ADHESIVE
ADHEZION BIOMEDICAL, LLC          510(k) NO: K130474(ABBREVIATED)
ATTN: CARIDAD  SMITH              PHONE NO : 828 572 4201   
ONE MERIDIAN PARKWAY SUITE 1B02   SE DECISION MADE: 31-MAY-13
WYOMISSING PA 19610               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SINGLE ENERGY (SE) FEMUR EXAMS
HOLOGIC, INC.                     510(k) NO: K130277(TRADITIONAL)
ATTN: EILEEN M BOYLE              PHONE NO : 781 999 7781   
35 CROSBY DR.                     SE DECISION MADE: 31-MAY-13
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEOMED EXTREMIFUSE SYSTEM
OSTEOMED                          510(k) NO: K130412(TRADITIONAL)
ATTN: PIEDAD  PENA                PHONE NO : 972 677 4784   
3885 ARAPAHO ROAD                 SE DECISION MADE: 31-MAY-13
ADDISON TX 75001                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
SPINEART                          510(k) NO: K130267(TRADITIONAL)
ATTN: FRANCK  PENNESI             PHONE NO : 41 22 7994025
COINTRIN 20 ROUTE DE PRE-BOIS CP18SE DECISION MADE: 31-MAY-13
GENEVA    SZ 1215                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOFORM RECONSTRUCTIVE TEMPLATE
MESYNTHE LTD                      510(k) NO: K130547(TRADITIONAL)
ATTN: RONALD  WARREN              PHONE NO : 858 753 1961   
11440 W. BERNARDO CT SUITE 300    SE DECISION MADE: 31-MAY-13
SAN DIEGO CA 92127                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLUCOSE METER-CHECK SOLUTION FOR TAIDOC
BIONOSTICS, INC.                  510(k) NO: K131136(TRADITIONAL)
ATTN: RANDY  BYRD                 PHONE NO : 978 862 1830   
7 JACKSON RD.                     SE DECISION MADE: 31-MAY-13
Devens MA 01434                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHT-6500, PHT-60CFO
VATECH CO., LTD.                  510(k) NO: K130432(SPECIAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 31-MAY-13
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS
IMPEDIMED LIMITED                 510(k) NO: K130338(TRADITIONAL)
ATTN: JOHN J SMITH, M.D., J.D.    PHONE NO : 202 637 3638   
555 13TH STREET, NW               SE DECISION MADE: 31-MAY-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITROS CHEMISTRY PRODUCTS TRIG SLIDES
ORTHO-CLINICAL DIAGNOSTICS, INC.  510(k) NO: K130332(SPECIAL)
ATTN: GAOZHEN  HANG               PHONE NO : 585 453 3962   
100 INDIGO CREEK DR.              SE DECISION MADE: 31-MAY-13
ROCHESTER NY 14626 5101           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAXTORQUE SCREW SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K131324(TRADITIONAL)
ATTN: BRIAN  HOCKETT              PHONE NO : 330 869 9562   
1065 Medina Rd. SUITE 500         SE DECISION MADE: 31-MAY-13
Medina OH 44256                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER
COOK, INC.                        510(k) NO: K130293(SPECIAL)
ATTN: DAVID E CHADWICK            PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 31-MAY-13
Blmgtn IN 47404                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM
ARTHREX, INC.                     510(k) NO: K130129(TRADITIONAL)
ATTN: COURTNEY  SMITH             PHONE NO : 239 643 5553   
1370 Creekside Blvd               SE DECISION MADE: 31-MAY-13
Naples FL 34108                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PELVIS II IMPLANT SYSTEM
STRYKER TRAUMA AG                 510(k) NO: K131132(TRADITIONAL)
ATTN: ELIJAH  WREH                PHONE NO : 201 831 5691   
325 CORPORATE DRIVE               SE DECISION MADE: 31-MAY-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXTSTEP RETROGRADE
ARROW INTERNATIONAL, INC.         510(k) NO: K130192(TRADITIONAL)
ATTN: GWEN  TASCHNER              PHONE NO : 610 378 0131   
2400 BERNVILLE RD.                SE DECISION MADE: 10-MAY-13
READING PA 19605                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANGE SPINAL SYSTEM
K2M, INC.                         510(k) NO: K130330(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR.,SE                 SE DECISION MADE: 02-MAY-13
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUPERA VERITAS
IDEV TECHNOLOGIES, INC.           510(k) NO: K130591(TRADITIONAL)
ATTN: DARLENE  GARNER             PHONE NO : 281 525 2000   
253 MEDICAL CENTER BLVD           SE DECISION MADE: 02-MAY-13
WEBSTER TX 77598                  510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   261                                     
                                                 TOTAL WITH SUMMARIES        236                                     
                                                 TOTAL WITH STATEMENTS        25