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U.S. Department of Health and Human Services

Medical Devices

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December 2013 510(k) Clearances

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


DEVICE: COBAS CT/NG V2.0 TEST
ROCHE MOLECULAR SYSTEMS, INC.     510(k) NO: K132270(TRADITIONAL)
ATTN: WILK  VON GUSTEDT           PHONE NO : 925 730 8046   
4300 HACIENDA DRIVE               SE DECISION MADE: 02-DEC-13
PLEASANTON CA 94588 2722          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3
ROCHE DIAGNOSTICS                 510(k) NO: K132828(TRADITIONAL)
ATTN: KELLI  TURNER               PHONE NO : 317 521 4515   
9115 HAGUE ROAD                   SE DECISION MADE: 04-DEC-13
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
AESKU.DIAGNOSTICS                 510(k) NO: K132082(TRADITIONAL)
ATTN: SASCHA  PFEIFFER            PHONE NO : 49 6734 96270
MIKROFORUM RING 2                 SE DECISION MADE: 05-DEC-13
WENDELSHEIM    GM D-55234         510(k) STATEMENT

DEVICE: GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
INFOPIA CO., LTD                  510(k) NO: K132966(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
1515 E KATELLA AVE UNIT 2115      SE DECISION MADE: 05-DEC-13
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)
DAKO NORTH AMERICA, INC.          510(k) NO: K130861(TRADITIONAL)
ATTN: JENNIFER M CHAMBERS         PHONE NO : 805 566 3036   
6392 VIA REAL                     SE DECISION MADE: 09-DEC-13
CARPINTERIA CA 93013              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
INFOPIA CO., LTD                  510(k) NO: K132862(SPECIAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
1515 E KATELLA AVE UNIT 2115      SE DECISION MADE: 12-DEC-13
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENPRIME DRUGS OF ABUSE READER SYSTEM
GENPRIME, INC                     510(k) NO: K130082(TRADITIONAL)
ATTN: MAUREEN  GARNER             PHONE NO : 732 779 7422   
1983 HAZELWOOD ROAD               SE DECISION MADE: 20-DEC-13
TOMS RIVER NJ 08753               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
ACON LABORATORIES, INC.           510(k) NO: K130284(TRADITIONAL)
ATTN: QIYI  XIE                   PHONE NO : 858 875 8011   
10125 Mesa Rim Road               SE DECISION MADE: 20-DEC-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AGGREGUIDE
AGGREDYNE, INC.                   510(k) NO: K122162(TRADITIONAL)
ATTN: J. HARBEY  KNAUSS           PHONE NO : 832 675 9281   
11874 SOUTH EVELYN CIRCLE         SE DECISION MADE: 20-DEC-13
HOUSTON TX 77071                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
THE BINDING SITE                  510(k) NO: K132555(TRADITIONAL)
ATTN: PAUL  KENNY                 PHONE NO : 44 121 4569500
8 Calthorpe Road Edgbaston        SE DECISION MADE: 20-DEC-13
BIRMINGHAM    GB B15 1QT          510(k) STATEMENT

DEVICE: BD MAX MRSA XT, BD MAX INSTRUMENT
GENEOHM SCIENCES CANADA, INC.     510(k) NO: K133605(TRADITIONAL)
ATTN: PATRICIA  DIONNE            PHONE NO : 418 780 7783
2555 BOUL. DU PARC-TECHNOLOGIQUE  SE DECISION MADE: 20-DEC-13
QUEBEC    CA G19 4S5              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMPLIVUE GBS ASSAY
QUIDEL CORPORATION                510(k) NO: K133503(TRADITIONAL)
ATTN: RONALD H LOLLAR             PHONE NO : 740 589 3300   
2005 EAST STATE ST., SUITE 100    SE DECISION MADE: 20-DEC-13
ATHENS OH 45701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
PHADIA US INC.                    510(k) NO: K131821(TRADITIONAL)
ATTN: MARTIN R MANN               PHONE NO : 269 492 1957   
4169 COMMERCIAL AVE.              SE DECISION MADE: 23-DEC-13
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS
IMMUNODIAGNOSTIC SYSTEMS LTD.     510(k) NO: K123763(TRADITIONAL)
ATTN: MICK  FENTON                PHONE NO : 441 915190 660
10 DIDCOT WAY, BOLDEN BUSINESS PARSE DECISION MADE: 24-DEC-13
BOLDON, TYNE & WEAR    UK NE35 9PD510(k) STATEMENT

DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)
BECTON, DICKINSON AND COMPANY     510(k) NO: K132674(TRADITIONAL)
ATTN: MONICA E GIGUERE            PHONE NO : 410 316 4287   
7 LOVETON CIRCLE, MC 614          SE DECISION MADE: 27-DEC-13
SPARKS MD 21152                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KINSA SMART THERMOMETER
KINSA, INC.                       510(k) NO: K132514(TRADITIONAL)
ATTN: LAEL J PICKETT              PHONE NO : 651 900 5460   
603 GREENWICH ST. #101B           SE DECISION MADE: 02-DEC-13
NEW YORK NY 10014                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
HEINZ KURZ GMBH MEDIZINTECHNIK    510(k) NO: K130512(TRADITIONAL)
ATTN: KRISTINA  BITZER            PHONE NO : 004 970 7291790
TUBINGER STRASSE 3                SE DECISION MADE: 02-DEC-13
DUSSLINGEN    GM D-72144          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONIXGPS
ULTRASONIX MEDICAL CORPORATION    510(k) NO: K121812(TRADITIONAL)
ATTN: RAYMOND  KELLY              PHONE NO : 203 880 4091   
57 LAZY BROOK RD.                 SE DECISION MADE: 02-DEC-13
MONROE CT 06468                   510(k) STATEMENT

DEVICE: CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE
ASIA-MED GMBH AND CO KG           510(k) NO: K132896(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
33 GOLDEN EAGLE LANE              SE DECISION MADE: 02-DEC-13
LITTLETON CO 80127                510(k) STATEMENT

DEVICE: OPTIFIX ABSORBABLE FIXATION SYSTEM
C.R. BARD, INC.                   510(k) NO: K132134(TRADITIONAL)
ATTN: RADHIKA  PONDICHERRY        PHONE NO : 401 825 8464   
100 CROSSINGS BOULEVARD           SE DECISION MADE: 02-DEC-13
WARWICK RI 02886                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 1ST MTP PLATE
OSTEOMED                          510(k) NO: K133437(SPECIAL)
ATTN: BLESSON  ABRAHAM            PHONE NO : 972 677 4795   
3885 ARAPAHO ROAD                 SE DECISION MADE: 02-DEC-13
ADDISON TX 75001                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVANT LASER
AVANT WELLNESS SYSTEMS, LLC       510(k) NO: K123474(ABBREVIATED)
ATTN: ANDY  HEWITSON              PHONE NO : 949 682 8268   
1020 CALLE CORDILLERA, STE 107    SE DECISION MADE: 03-DEC-13
SAN CLEMENTE CA 92673             510(k) STATEMENT

DEVICE: SURGISEAL TOPICAL SKIN ADHESIVE
ADHEZION BIOMEDICAL, LLC          510(k) NO: K130329(ABBREVIATED)
ATTN: CARIDAD  SMITH              PHONE NO : 828 572 4201   
ONE MERIDIAN PARKWAY SUITE 1B02   SE DECISION MADE: 03-DEC-13
WYOMISSING PA 19610               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURVEYOR CENTRAL STATION
MORTARA INSTRUMENT, INC.          510(k) NO: K131929(ABBREVIATED)
ATTN: AMY  YANG                   PHONE NO : 414 354 1600   
7865 NORTH 86TH ST.               SE DECISION MADE: 03-DEC-13
MILWAUKEE WI 53224                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM
CIANNA MEDICAL, INC.              510(k) NO: K132463(TRADITIONAL)
ATTN: GARY  MOCNIK                PHONE NO : 949 360 0059   
6 JOURNEY SUITE 125               SE DECISION MADE: 03-DEC-13
ALISO VIEJO CA 92656              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M-VU BREAST DENSITY
VUCOMP, INC.                      510(k) NO: K132742(TRADITIONAL)
ATTN: RICHARD  MORRONEY           PHONE NO : 888 266 7462   
2500 NORTH DALLAS PARKWAY SUITE 50SE DECISION MADE: 03-DEC-13
PLANO TX 75093                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR
MEDTRONIC ADVANCED ENERGY, LLC    510(k) NO: K132974(TRADITIONAL)
ATTN: GABRIELA  ANCHONDO          PHONE NO : 904 279 7550   
180 INTERNATIONAL DRIVE           SE DECISION MADE: 03-DEC-13
Portsmouth NH 03801               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HARVESTING CANNULA
MAQUET CARDIOVASCULAR, LLC        510(k) NO: K132743(TRADITIONAL)
ATTN: MARK  DINGER                PHONE NO : 973 709 7691   
45 BARBOUR POND DRIVE             SE DECISION MADE: 03-DEC-13
WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEM-O-LOK LIGATING CLIP
TELEFLEX MEDICAL                  510(k) NO: K133202(TRADITIONAL)
ATTN: ASHLEA  RICCI               PHONE NO : 919 433 8065   
2917 WECK DR.                     SE DECISION MADE: 03-DEC-13
RESEARCH TRIANGLE PARK NC 27709   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY
ETHICON ENDO-SURGERY, LLC         510(k) NO: K133314(TRADITIONAL)
ATTN: BRIAN  GODWIN               PHONE NO : 513 337 3623   
4545 CREEK ROAD                   SE DECISION MADE: 03-DEC-13
CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258)
JVC KENWOOD CORPORATION           510(k) NO: K133181(TRADITIONAL)
ATTN: TSUKASA  TASHIRO            PHONE NO : 812 582466 1
3-12, MORIYACHO, KANAGAWA-KU      SE DECISION MADE: 03-DEC-13
YOKOHAMA-SHI, KANAGAWA    JA 221-0510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358)
JVC KENWOOD CORPORATION           510(k) NO: K133185(TRADITIONAL)
ATTN: TSUKASA  TASHIRO            PHONE NO : 81 258246 611
3-12, MORIYACHO, KANAGAWA-KU      SE DECISION MADE: 03-DEC-13
YOKOHAMA-SHI, KANAGAWA    JA 221-0510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIPRO PUREFLUX-L HEMODIALYZER
NIPRO MEDICAL CORPORATION         510(k) NO: K122952(TRADITIONAL)
ATTN: CAROLYN  GEAORGE            PHONE NO : 678 947 3429   
6695 RIVER CREST PT               SE DECISION MADE: 04-DEC-13
SUWANEE GA 30024                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SELF-RETAINING BICANALICULUS INTUBATON SET II
FCI SAS (FRANCE CHIRURGIE INSTRUME510(k) NO: K130375(TRADITIONAL)
ATTN: BARBARA S FANT              PHONE NO : 513 961 8200   
3308 JEFFERSON AVENUE UPPER LEVEL SE DECISION MADE: 04-DEC-13
CINCINNATI OH 45220               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYLABSEVEN 6400, MYLABALPHA 7400
ESAOTE S.P.A.                     510(k) NO: K132466(TRADITIONAL)
ATTN: ALLISON  SCOTT              PHONE NO : 317 569 9500   
9001 WESLEYAN RD. SUITE 200       SE DECISION MADE: 04-DEC-13
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERIMETER C SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K132584(TRADITIONAL)
ATTN: MICHAEL  SCOTT              PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 04-DEC-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
COVIDIEN                          510(k) NO: K132604(SPECIAL)
ATTN: KELSEY  LEE                 PHONE NO : 303 305 2760   
6135 GUNBARREL AVE.               SE DECISION MADE: 04-DEC-13
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARESCAPE MONITOR B450
GE HEALTHCARE FINLAND OY          510(k) NO: K132533(TRADITIONAL)
ATTN: JOEL  KENT                  PHONE NO : 358 10 39411
KUORTANEENKATU 2                  SE DECISION MADE: 04-DEC-13
HELSINKI    FI FIN-00510          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM
MINILAP TECHNOLOGIES              510(k) NO: K132232(TRADITIONAL)
ATTN: ALLAN  ALWARD               PHONE NO : 914 479 5108   
145 PALISADE STREET               SE DECISION MADE: 04-DEC-13
DOBBS FERRY NY 10522              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S HEALTH
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K132148(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
129, SAMSUNG-RO, YEONGTONG-GU     SE DECISION MADE: 04-DEC-13
SUWON-SI, GYEONGGI-DO    KS 443-74510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK
SHOFU DENTAL CORPORATION          510(k) NO: K132748(TRADITIONAL)
ATTN: DAVID P MORAIS              PHONE NO : 760 736 3277   
1225 STONE DRIVE                  SE DECISION MADE: 04-DEC-13
SAN MARCOS CA 92078               510(k) STATEMENT

DEVICE: HEINE BETA 200(R) OPHTHALMOSCOPE
HEINE OPTOTECHNIK GMBH & CO. KG.  510(k) NO: K131961(ABBREVIATED)
ATTN: MANFRED  BARTSCH-TITTMANN   PHONE NO : 49 815238 419
KIENTALSTRASSE 7                  SE DECISION MADE: 04-DEC-13
HERRSCHING    GM D-82211          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BM3/BM3 PLUS
NOBLITT & RUELAND                 510(k) NO: K132033(TRADITIONAL)
ATTN: MARC  GOODMAN               PHONE NO : 949 398 5222   
5405 ALTON PARKWAY SUITE A530     SE DECISION MADE: 04-DEC-13
IRVINE CA 92604 3718              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MARS HOLTER ANALYSIS WORKSTATION
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K132437(SPECIAL)
ATTN: KRISTIN  PABST              PHONE NO : 414 721 3104   
9900 WEST INNOVATION DRIVE        SE DECISION MADE: 04-DEC-13
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT
FISHER & PAYKEL HEALTHCARE, LTD.  510(k) NO: K131957(TRADITIONAL)
ATTN: ELIZABETH  GOLDSTEIN        PHONE NO : 649 57 40100
15 MAURICE PAYKEL PLACE EAST TAMAKSE DECISION MADE: 04-DEC-13
ACKLAND    NZ 2013                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE
MEDSHAPE, INC                     510(k) NO: K130467(TRADITIONAL)
ATTN: KENNETH M DUPONT, PH.D.     PHONE NO : 678 235 3336   
1575 NORTHSIDE DRIVE NW SUITE 440 SE DECISION MADE: 05-DEC-13
ATLANTA GA 30318                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPELLA
FUTURE MOBILITY HEALTHCARE INC.   510(k) NO: K130788(TRADITIONAL)
ATTN: ABDULSAMAD  PANCHBHAYA      PHONE NO : 905 671166 1
3223 Orlando Drive                SE DECISION MADE: 05-DEC-13
MISSISSAUGA    CA L4V 1C5         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BOND APATITE
AUGMA BIOMATERIALS, LTD.          510(k) NO: K121177(TRADITIONAL)
ATTN: KEVIN A THOMAS              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 05-DEC-13
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
AMERICAN MEDICAL SYSTEMS          510(k) NO: K131229(SPECIAL)
ATTN: TODD  HILDEBRANDT           PHONE NO : 952 930 6000   
10700 BREN ROAD WEST              SE DECISION MADE: 05-DEC-13
MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS
EL.EN. ELECTRONIC ENGINEERING SPA 510(k) NO: K131095(TRADITIONAL)
ATTN: PAOLO  PERUZZI              PHONE NO : 39 055 8826807
17 VIA BALDANZESE                 SE DECISION MADE: 05-DEC-13
CALENZANO    IT 50041             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
CORELINK LLC                      510(k) NO: K132994(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 05-DEC-13
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UD IMPLANT SYSTEM
MEDIMECCA CO., LTD.               510(k) NO: K131682(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
1515 E KATELLA AVE UNIT 2115      SE DECISION MADE: 05-DEC-13
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MCKESSON CARDIOLOGY HEMO
MCKESSON ISRAEL LTD.              510(k) NO: K131497(TRADITIONAL)
ATTN: PAUL  SUMNER                PHONE NO : 404 338 3556   
5995 WINDWARD PARKWAY             SE DECISION MADE: 05-DEC-13
ALPHARETTA GA 30005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
CONFORMIS, INC.                   510(k) NO: K132640(TRADITIONAL)
ATTN: AMITA  SHAH                 PHONE NO : 781 345 9164   
28 Crosby Dr                      SE DECISION MADE: 05-DEC-13
Bedford MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TFCC FAST-FIX KIT
SMITH & NEPHEW, INC.              510(k) NO: K132079(TRADITIONAL)
ATTN: JASON  SELLS                PHONE NO : 901 399 5520   
150 MINUTEMAN RD.                 SE DECISION MADE: 05-DEC-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AEQUALIS REVERSED SHOULDER PROSTHESIS
TORNIER, SAS                      510(k) NO: K132285(TRADITIONAL)
ATTN: MAGALIE  HENNEQUIN          PHONE NO : 330 47 6613500
161. RUE LAVOISIER                SE DECISION MADE: 05-DEC-13
MONTBONNOT SAINT MARTIN    FR 3833510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIEHM VISION RFD
ZIEHM IMAGING GMBH                510(k) NO: K132904(SPECIAL)
ATTN: RICHARD L WESTRICH          PHONE NO : 407 615 8560   
6280 HAZELTINE NATIONAL DR.       SE DECISION MADE: 05-DEC-13
ORLANDO FL 32822                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STARCERAM
H.C. STARCK CERAMICS GMBH         510(k) NO: K133213(TRADITIONAL)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 05-DEC-13
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER
NIPRO MEDICAL CORPORATION         510(k) NO: K132153(TRADITIONAL)
ATTN: JESSICA  OSWALD-MCLEOD      PHONE NO : 305 599 7174   
3150 N.W. 107TH AVE.              SE DECISION MADE: 05-DEC-13
MIAMI FL 33172                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT
TORNIER, INC.                     510(k) NO: K133376(SPECIAL)
ATTN: JANELL A COLLEY             PHONE NO : 952 426 7600   
10801 NESBITT AVENUE SOUTH        SE DECISION MADE: 05-DEC-13
BLOOMINGTON MN 55437              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALERE BINAXNOW INFLUENZA A & B CARD
ALERE SCARBOROUGH, INC D/B/A BINAX510(k) NO: K133411(SPECIAL)
ATTN: ANGELA  DRYSDALE            PHONE NO : 207 730 5737   
10 Southgate Rd                   SE DECISION MADE: 05-DEC-13
Scarborough ME 04074              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
ENGINEERED MEDICAL SOLUTIONS CO. L510(k) NO: K133425(SPECIAL)
ATTN: RYAN  SAVAGE                PHONE NO : 908 329 9123   
85 INDUSTRIAL DR. BUILDING B      SE DECISION MADE: 05-DEC-13
PHILLIPSBURG NJ 08865             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT
STRYKER                           510(k) NO: K132519(TRADITIONAL)
ATTN: ROB  YAMASHITA              PHONE NO : 269 389 4258   
750 TRADE CENTRE WAY STE 200      SE DECISION MADE: 06-DEC-13
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEOMED NEURO RONGEUR
OSTEOMED                          510(k) NO: K131851(TRADITIONAL)
ATTN: PIEDAD  PENA, M.S.          PHONE NO : 972 677 4600   
3885 ARAPAHO ROAD                 SE DECISION MADE: 06-DEC-13
ADDISON TX 75001                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS
OLSEN MEDICAL                     510(k) NO: K130669(TRADITIONAL)
ATTN: DALENE  BINKLEY             PHONE NO : 260 244 4189   
1927 N. ARTHUR DR.                SE DECISION MADE: 06-DEC-13
COLUMBIA CITY IN 46725            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FAMILY OF COOLGLIDE AESTHETIC LASERS
CUTERA, INC.                      510(k) NO: K132185(TRADITIONAL)
ATTN: SANDRA  HANSEN              PHONE NO : 415 657 5526   
3240 BAYSHORE BLVD                SE DECISION MADE: 06-DEC-13
BRISBANE CA 94005                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE
COMPRESSION WORKS, LLC            510(k) NO: K133029(TRADITIONAL)
ATTN: MICHAEL  FORSTADT           PHONE NO : 401 521 3294   
15 SARGENT AVE                    SE DECISION MADE: 06-DEC-13
PROVIDENCE RI 02906               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET
TERUMO BCT, INC..                 510(k) NO: K132429(TRADITIONAL)
ATTN: TINA  O'BRIEN               PHONE NO : 303 239 2082   
10811 WEST COLLINS AVE.           SE DECISION MADE: 06-DEC-13
LAKEWOOD CO 80215 4415            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K SERIES CPAP SYSTEMS
CURATIVE MEDICAL INC.             510(k) NO: K131702(TRADITIONAL)
ATTN: AMY  MCKINNEY               PHONE NO : 979 236 1622   
6518 TAMARIND SKY LN.             SE DECISION MADE: 06-DEC-13
FULSHEAR TX 77441                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIEZON 250
E.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K132445(SPECIAL)
ATTN: CYNTHIA  NOLTE              PHONE NO : 919 859 4207   
62 FOREST ST., STE 300            SE DECISION MADE: 06-DEC-13
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGAPASS
MEDICREA INTERNATIONAL            510(k) NO: K132395(TRADITIONAL)
ATTN: AUDREY  VION                PHONE NO : 33 472 018787
14 PORTE DU GRAND LYON            SE DECISION MADE: 06-DEC-13
NEYRON    FR 01700                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET
ENTHERMICS MEDICAL SYSTEMS, INC.  510(k) NO: K132202(TRADITIONAL)
ATTN: ADAM  VAN ESSEN             PHONE NO : 262 251 8356   
WEST 164 NORTH 9221 WATER ST.     SE DECISION MADE: 06-DEC-13
MENOMONEE FALLS WI 53051          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANESTHESIA CONDUCTION NEEDLES
LCCS PRODUCTS LIMITED             510(k) NO: K131006(TRADITIONAL)
ATTN: MIKE  GU                    PHONE NO : 86 20 62321333
7TH FLOOR, JINGGUI BUSINESS BUILDISE DECISION MADE: 06-DEC-13
GUANGZHOU, GUANGDONG    CH 510420 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INNO SLA SUBMERGED IMPLANT SYSTEM
COWELLMEDI CO., LTD               510(k) NO: K132242(TRADITIONAL)
ATTN: SUSAN  PARK                 PHONE NO : 714 525 0114   
325 N. PUENTE ST UNIT B           SE DECISION MADE: 06-DEC-13
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K130004(TRADITIONAL)
ATTN: JANIS  TARANTO              PHONE NO : 508 683 4560   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 06-DEC-13
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K132328(TRADITIONAL)
ATTN: BECKY  RONNER               PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 06-DEC-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAXX(R) SYSTEM
SPINE WAVE, INC.                  510(k) NO: K133207(SPECIAL)
ATTN: JOSEPH  MERCADO             PHONE NO : 203 944 9494   
THREE ENTERPRISE DR. SUITE 210    SE DECISION MADE: 06-DEC-13
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP
3B MEDICAL, INC                   510(k) NO: K132967(SPECIAL)
ATTN: ALEX  LUCIO                 PHONE NO : 863 226 6285   
21301 HWY 27 N                    SE DECISION MADE: 06-DEC-13
Lake Wales FL 33859               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
ANGIOSLIDE, LTD                   510(k) NO: K133043(TRADITIONAL)
ATTN: CLAY  ANSELMO               PHONE NO : 303 223 4303   
11925 W I-70 FRONTAGE RAOD NORTH  SE DECISION MADE: 06-DEC-13
WHEAT RIDGE CO 80033              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CROSSTREES PVA POD
CROSSTREES MEDICAL, INC.          510(k) NO: K133372(SPECIAL)
ATTN: JANICE  HOGAN               PHONE NO : 267 675 4611   
135 MARKET ST., 29TH FLOOR        SE DECISION MADE: 06-DEC-13
PHILADELPHIA PA 19119             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
ETHICON, INC.                     510(k) NO: K133356(SPECIAL)
ATTN: ELLIOTT  JANG               PHONE NO : 908 541 3817   
ROUTE 22 WEST                     SE DECISION MADE: 06-DEC-13
SOMERVILLE NJ 08876 0151          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEART SYNC
HEART SYNC INC.                   510(k) NO: K131550(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 06-DEC-13
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO.PLAZA VB10A
SIEMENS AG HEALTHCARE             510(k) NO: K132532(TRADITIONAL)
ATTN: VIKTORIA  BENZ              PHONE NO : 49 913184 4483
HENKESTRASSE 127                  SE DECISION MADE: 09-DEC-13
ERLANGEN    GM 91052              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VENT-OS SINUS DILATION SYSTEM
SINUSYS CORPORATION               510(k) NO: K133016(TRADITIONAL)
ATTN: MICHAELE A DANIEL           PHONE NO : 925 254 5228   
8 SNOWBERRY COURT                 SE DECISION MADE: 09-DEC-13
ORINDA CA 94563                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROPRIETARY / DONGTAI/ OTHER CLIENTS PRIVATE LABELING
DONG TAI CITY HUAYI GLOVES CO., LT510(k) NO: K131823(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 86 10 8238744
RM 1606 BLDG, 1 JIAN XIANG YUAN NOSE DECISION MADE: 09-DEC-13
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PONTO PLUS AND PONTO PLUS POWER
OTICON MEDICAL AB                 510(k) NO: K132775(TRADITIONAL)
ATTN: SATU  HJARTSTAM             PHONE NO : 46 31 7486100
EKONOMIVAGEN 2                    SE DECISION MADE: 09-DEC-13
ASKIM    SW SE-436 33             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K7 LUMBAR SPACERS
K7 LLC                            510(k) NO: K133126(TRADITIONAL)
ATTN: KAREN E WARDEN, PHD         PHONE NO : 440 729 8457   
PO BOX 566                        SE DECISION MADE: 09-DEC-13
CHESTERLAND OH 44026 2141         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXOSHAPE DUO SOFT TISSUE FASTENER
MEDSHAPE, INC                     510(k) NO: K132783(TRADITIONAL)
ATTN: STEPHEN  LAFFOON            PHONE NO : 678 235 3324   
1575 NORTHSIDE DRIVE NW SUITE 440 SE DECISION MADE: 09-DEC-13
ATLANTA GA 30318                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
ELLIPSE TECHNOLOGIES, INC.        510(k) NO: K133289(SPECIAL)
ATTN: JOHN  MCINTYRE              PHONE NO : 949 837 3600   
13900 Alton Pkwy Ste 123          SE DECISION MADE: 09-DEC-13
Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
SMITHS MEDICAL ASD, INC.          510(k) NO: K130394(TRADITIONAL)
ATTN: PAULA  CORDERO              PHONE NO : 651 628 7824   
1265 GREY FOX ROAD                SE DECISION MADE: 09-DEC-13
ST. PAUL MN 55112                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CPR RSQ ASSIST
AVANTECH, INC.                    510(k) NO: K123248(TRADITIONAL)
ATTN: STEVEN B DATLOF             PHONE NO : 267 675 4613   
1835 MARKET ST, 29TH FLOOR        SE DECISION MADE: 10-DEC-13
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
MAKO SURGICAL CORPORATION         510(k) NO: K133039(SPECIAL)
ATTN: JONATHAN  REEVES            PHONE NO : 954 628 0665   
2555 DAVIE ROAD                   SE DECISION MADE: 10-DEC-13
FORT LAUDERDALE FL 33317          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOSIGN FLU A + B, STATUS FLU A & B
PRINCETON BIOMEDITECH CORP.       510(k) NO: K133474(SPECIAL)
ATTN: KYUNG-AH  KIM               PHONE NO : 732 274 1000   
4242 U.S. RT. 1                   SE DECISION MADE: 10-DEC-13
MONMOUTH JUNCTION NJ 08852 1905   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TG-BODY MI&BODY S-TRAINER
MIGA MEDICAL CO., LTD.            510(k) NO: K122393(TRADITIONAL)
ATTN: YANG HO  DONG               PHONE NO : 082 256 63360
#821 SAMIL PLAZA 837-26 YEUKSAM-DOSE DECISION MADE: 10-DEC-13
GANGNAM-GU    KS 135-768          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CANCARY BREATHING SYSTEM
PALO ALTO HEALTH SCIENCES, INC.   510(k) NO: K131586(TRADITIONAL)
ATTN: LORI  ADELS, PHD            PHONE NO : 408 400 0856   
755 N MATHILDA AVE SUITE 100      SE DECISION MADE: 10-DEC-13
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS
SMITH & NEPHEW, INC.              510(k) NO: K130708(TRADITIONAL)
ATTN: BRADLEY  HEIL               PHONE NO : 901 399 6339   
1450 BROOKS RD.                   SE DECISION MADE: 11-DEC-13
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER
KRONNER PROTOTYPES, INC.          510(k) NO: K130758(TRADITIONAL)
ATTN: RICHARD F KRONNER, M.D.     PHONE NO : 541 672 2543   
1443 UPPER CLEVELAND RAPIDS RD    SE DECISION MADE: 11-DEC-13
ROSEBURG OR 97471                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLYSITE IMPLANTABLE INFUSION PORTS
PEROUSE MEDICAL                   510(k) NO: K122834(TRADITIONAL)
ATTN: ISABELLE  JEANTY            PHONE NO : 33 34 4081700
Route du Manoir Ivry-le-Temple    SE DECISION MADE: 11-DEC-13
FRANCE    FR 60173                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RETRIEVAL BAG
FLEXBAR MACHINE CORP.             510(k) NO: K123728(ABBREVIATED)
ATTN: STEPHEN T MLCOCH            PHONE NO : 631 744 0059   
30 NORTHPORT ROAD                 SE DECISION MADE: 11-DEC-13
SOUND BEACH NY 11789              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM
GENESYS SPINE                     510(k) NO: K130317(TRADITIONAL)
ATTN: WILLIAM W SOWERS            PHONE NO : 512 381 7080   
1250 CAPITAL OF TEXAS HWY SO. BUILSE DECISION MADE: 11-DEC-13
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLYDESDALE SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K132897(TRADITIONAL)
ATTN: BRAD  SHEALS                PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 11-DEC-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ME
SYNERON BEAUTY LTD.               510(k) NO: K131649(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET ST., 29TH FLOOR       SE DECISION MADE: 11-DEC-13
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTHERA SYSTEM
ULTHERA, INC.                     510(k) NO: K132028(TRADITIONAL)
ATTN: SUZON  LOMMEL               PHONE NO : 480 619 4069   
2150 S. Country Club Drive Suite 2SE DECISION MADE: 11-DEC-13
Mesa AZ 85210                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIDEXIS 4
SIRONA DENTAL SYSTEMS GMBH        510(k) NO: K132773(TRADITIONAL)
ATTN: FRITZ  KOLLE                PHONE NO : 49 625 1160
FABRIKSTRASSE 31                  SE DECISION MADE: 11-DEC-13
BENSHEIM    GM D-64625            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERTEX OCT SPINAL IMPLANT SYSTEM
X-SPINE SYSTEMS, INC              510(k) NO: K133094(TRADITIONAL)
ATTN: DAVID  KIRSCHMAN, M.D.      PHONE NO : 937 847 8400   
452 Alexandersville Rd            SE DECISION MADE: 11-DEC-13
Miamisburg OH 45342               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WOUND MEASURING & MONITORING DEVICE
WOUNDVISION, LLC                  510(k) NO: K131596(TRADITIONAL)
ATTN: GRETCHEN  MILLER BOWKER     PHONE NO : 317 445 7790   
29 EAST MCCARTY STREET SUITE 100  SE DECISION MADE: 11-DEC-13
INDIANAPOLIS IN 46225             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VANGUARD XP KNEE SYSTEM
BIOMET, INC.                      510(k) NO: K132873(TRADITIONAL)
ATTN: JULIE  GANTENBERG, M.S.     PHONE NO : 574 377 8133   
56 EAST BELL DRIVE                SE DECISION MADE: 11-DEC-13
WARSAW IN 46581                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVINENT DENTAL IMPLANT SYSTEM
AVINENT IMPLANT SYSTEM, S.L.      510(k) NO: K121873(ABBREVIATED)
ATTN: ANNA  CORTINA               PHONE NO : 003 490 2383848
POL. IND SANTA ANNA APARTAT 20    SE DECISION MADE: 11-DEC-13
SANTPEDOR    SP 08251             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ERBE ESU MODEL VIO DV WITH ACCESSORIES
ERBE USA, INC.                    510(k) NO: K133180(SPECIAL)
ATTN: JOHN  TARTAL                PHONE NO : 770 955 4400   
2225 NORTHWEST PKWY.              SE DECISION MADE: 11-DEC-13
MARIETTA GA 30067                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THD N-ANO ANOSCOPE
THD SPA                           510(k) NO: K133687(SPECIAL)
ATTN: GUIDO  BONAPACE             PHONE NO : 393 355 378686
VIA A.ALTOBELLI BONETTI, 3/A      SE DECISION MADE: 11-DEC-13
IMOLA, BO    IT 40026             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIDI DENTAL IMPLANT SYSTEM
AIDI BIOMEDICAL LLC               510(k) NO: K123861(TRADITIONAL)
ATTN: CHEN  TIAN                  PHONE NO : 951 678 9626   
34859 FREDERICK ST #105           SE DECISION MADE: 12-DEC-13
WILDOMAR CA 92595                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING
CHONGQING PSK SCI-TECH DEVELOPMENT510(k) NO: K130439(TRADITIONAL)
ATTN: FIELD  FU                   PHONE NO : 
05C. FUHAI KANGLE BUILDING NANSHANSE DECISION MADE: 12-DEC-13
SHENZHEN, GUANGDONG    CH 518000  510(k) STATEMENT

DEVICE: MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
DATASCOPE CORP.                   510(k) NO: K133074(SPECIAL)
ATTN: LINDA  SLUTZKY              PHONE NO : 973 709 7973   
15 LAW DR.                        SE DECISION MADE: 12-DEC-13
FAIRFIELD NJ 07004 3206           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDCOMP GEN III POWER INJECTABLE PORT
MEDCOMP (MEDICAL COMPONENTS)      510(k) NO: K132177(TRADITIONAL)
ATTN: SARAH  SHAFFER              PHONE NO : 215 256 4201   
1499 DELP DRIVE                   SE DECISION MADE: 12-DEC-13
HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WTF SECURA SYRINGE AND NEEDLE
BEIJING WANTEFU MEDICAL APPARATUS 510(k) NO: K132120(TRADITIONAL)
ATTN: RAYMOND  SUN                PHONE NO : 861 06 0750950
NANTOU INDUSTRIAL PARK MACHIKOU   SE DECISION MADE: 12-DEC-13
BEIJING    CH 102200              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNC-RX SYSTEM
VOLCANO CORPORATION               510(k) NO: K132558(TRADITIONAL)
ATTN: ELAINE  ALAN                PHONE NO : 978 439 3357   
1 FORTUNE DRIVE                   SE DECISION MADE: 12-DEC-13
BILLERICA MA 01821                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INQWIRE DIAGNOSTIC GUIDE WIRE
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K133230(SPECIAL)
ATTN: SIOBHAN  KING               PHONE NO : 353 91 703700
PARKMORE BUSINESS PARK WEST       SE DECISION MADE: 12-DEC-13
GALWAY    EI EI                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYOPERFUSION
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K132523(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DRIVE               SE DECISION MADE: 12-DEC-13
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK
MEDAPPS INC., DBA ALERE CONNECT   510(k) NO: K132803(SPECIAL)
ATTN: KENT  DICKS                 PHONE NO : 480 305 6323   
8767 E. VIA DE VENTURA, STE 300   SE DECISION MADE: 12-DEC-13
SCOTTSDALE AZ 85258               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEOGEN PSR SYSTEM
ENERGIST, LTD.                    510(k) NO: K132754(TRADITIONAL)
ATTN: DARREN  THOMAS              PHONE NO : 44 1792 798768
2 PARK PAVILIONS, CLOS LLYN CWM ENSE DECISION MADE: 12-DEC-13
SWANSEA    UK SA6 8QY             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLATINUM DRF IMAGING SYSTEM
APELEM-DMS GROUP                  510(k) NO: K131766(TRADITIONAL)
ATTN: SHARYN  ORTON               PHONE NO : 401 330 8264   
200 HOMER AVE                     SE DECISION MADE: 12-DEC-13
ASHLAND MA 01721                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133435(SPECIAL)
ATTN: NADIA  SOOKDEO              PHONE NO : 610 448 4918   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 12-DEC-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICRODOSE SI
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN510(k) NO: K130704(TRADITIONAL)
ATTN: GUSTAV  LINS                PHONE NO : 46 8 6235200
SMIDESVAGEN 5                     SE DECISION MADE: 13-DEC-13
SOLNA    SW SE-171 41             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM
GENESYS SPINE                     510(k) NO: K130913(SPECIAL)
ATTN: WILLIAM W SOWERS            PHONE NO : 512 381 7080   
1250 CAPITAL OF TEXAS HWY SO. BUILSE DECISION MADE: 13-DEC-13
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS
NANJING MAIDIXIN MEDICAL DEVICE CO510(k) NO: K130738(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 120-119                  SE DECISION MADE: 13-DEC-13
SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARD VENTRALEX HERNIA PATCH
C.R. BARD, INC.                   510(k) NO: K132441(SPECIAL)
ATTN: MARIYA  BUHARIN             PHONE NO : 401 825 8729   
100 CROSSINGS BLVD.               SE DECISION MADE: 13-DEC-13
WARWICK RI 02886                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DURABLUE STERILIZATION WRAP
CARDINAL HEALTH-MEDICAL PRODUCTS A510(k) NO: K132060(TRADITIONAL)
ATTN: LAVENIA  FORD               PHONE NO : 847 887 3323   
1430 WAUKEGAN RD.                 SE DECISION MADE: 13-DEC-13
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NORMED PELLEGRIN CALCANEUS STOP SCREW
NORMED MEDIZIN-TECHNIK GMBH       510(k) NO: K133035(TRADITIONAL)
ATTN: DALENE  BINKLEY             PHONE NO : 260 244 4189   
8708 CAPEHART COVE                SE DECISION MADE: 13-DEC-13
AUSTIN TX 78733                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
WRP ASIA PACIFIC SDN. BHD.        510(k) NO: K132484(TRADITIONAL)
ATTN: KIRK  PENNER                PHONE NO : 603 87 061486
LOT 1, JALAN 3, KAWASAN PERUSAHAANSE DECISION MADE: 13-DEC-13
SALAK TINGGI, SEPANG SELANGOR    M510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC
MOLLER MEDICAL GMBH               510(k) NO: K121248(TRADITIONAL)
ATTN: GRANT  GECKELER             PHONE NO : 714 312 6863   
1612 JENKS DRIVE                  SE DECISION MADE: 13-DEC-13
CORONA CA 92880                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROVANT THERAPY SYSTEM
REGENESIS BIOMEDICAL, INC.        510(k) NO: K131979(TRADITIONAL)
ATTN: RICHARD  ISENBERG           PHONE NO : 877 970 4970   
5301 NORTH PIMA ROAD SUITE 150    SE DECISION MADE: 13-DEC-13
SCOTTSDALE AZ 85250 3773          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S-SCAN
ESAOTE, S.P.A.                    510(k) NO: K131996(SPECIAL)
ATTN: ALLISON  SCOTT, RAC         PHONE NO : 317 569 9500   
9001 WESLEYAN ROAD SUITE 200      SE DECISION MADE: 13-DEC-13
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
SMITH & NEPHEW, INC.              510(k) NO: K132015(TRADITIONAL)
ATTN: BRADLEY  HEIL               PHONE NO : 901 399 6339   
150 MINUTEMAN RD.                 SE DECISION MADE: 13-DEC-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEPAFAT SCAN
RESONANCE HEALTH ANALYSIS SERVICES510(k) NO: K122035(TRADITIONAL)
ATTN: GREG  HOLLAND               PHONE NO : 949 262 0411   
3722 AVE. SAUSALITO               SE DECISION MADE: 13-DEC-13
IRVINE CA 92606                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES
GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K132240(TRADITIONAL)
ATTN: PATRICK  CHOW               PHONE NO : 008 522 8516789
ZHU KENG INDUSTRIAL ZONE PING SHANSE DECISION MADE: 16-DEC-13
SHENSHEN, GUANG DONG    CH 518118 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REMOVABLE PATIENT LEADS ECG CABLE
BOSTON SCIENTIFIC                 510(k) NO: K132253(TRADITIONAL)
ATTN: MELISSA  KLAMERUS           PHONE NO : 651 582 6771   
4100 HAMLINE AVE                  SE DECISION MADE: 16-DEC-13
ARDEN HILLS MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYALMIX CREAM
IGI LABORATORIES, INC.            510(k) NO: K123678(TRADITIONAL)
ATTN: FREDERICK  WEISS            PHONE NO : 856 697 1441   
105 LINCOLN AVE.                  SE DECISION MADE: 16-DEC-13
BUENA NJ 08310                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS
MIKRON MAKINA SANAYI VE TICARET LT510(k) NO: K130073(TRADITIONAL)
ATTN: OMAR  DIKER                 PHONE NO : 410 885 9978   
80 LEICESTER WAY                  SE DECISION MADE: 16-DEC-13
CHESAPEAKE CITY MD 21915          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARGUARD HD END CAP
PURSUIT VASCULAR, INC             510(k) NO: K131060(TRADITIONAL)
ATTN: LAURIE E LYNCH, PH.D.       PHONE NO : 612 424 9006   
6901 E. FISH LAKE ROAD SUITE 166  SE DECISION MADE: 16-DEC-13
MAPLE GROVE MN 55369              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ
BIOCHEMICAL DIAGNOSTICS, INC.     510(k) NO: K132688(TRADITIONAL)
ATTN: ALLEN  PANETZ               PHONE NO : 631 595 9200   
180 HEARTLAND BLVD.               SE DECISION MADE: 16-DEC-13
Edgewood NY 11717                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY
STRYKER ENDOSCOPY                 510(k) NO: K132785(TRADITIONAL)
ATTN: LIFEI  LIU                  PHONE NO : 408 754 2000   
5900 OPTICAL CT.                  SE DECISION MADE: 16-DEC-13
SAN JOSE CA 95138                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORIN METAFIX HIP STEM
CORIN USA                         510(k) NO: K131952(TRADITIONAL)
ATTN: LUCINDA  GERBER             PHONE NO : 813 977 4469   
5670 W. CYPRESS ST. SUITE C       SE DECISION MADE: 16-DEC-13
TAMPA FL 33607                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONETOUCH REVEAL
LIFESCAN, INC.                    510(k) NO: K132618(TRADITIONAL)
ATTN: GABRIELLE  LOGAN            PHONE NO : 484 328 6159   
965 CHESTERBROOK BOULEVARD        SE DECISION MADE: 16-DEC-13
WAYNE PA 19087                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUSIONSYNC, CHIMAERA FUSIONSYNC
CHIMAERA GMBH                     510(k) NO: K132963(TRADITIONAL)
ATTN: MARCUS  PRUEMMER            PHONE NO : 499 13 1691385
AM WEICHSELGARTEN 7               SE DECISION MADE: 16-DEC-13
ERLANGEN, BAVARIA    GM 91058     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
SYNTHES USA PRODUCTS, LLC         510(k) NO: K132910(TRADITIONAL)
ATTN: EUGENE  BANG                PHONE NO : 508 977 3966   
1302 WRIGHTS LANE EAST            SE DECISION MADE: 16-DEC-13
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
SYNTHES INC                       510(k) NO: K131792(TRADITIONAL)
ATTN: HEATHER  GUERIN             PHONE NO : 610 719 5432   
1301 GOSHEN PARKWAY               SE DECISION MADE: 16-DEC-13
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORIN MINIHIP STEM
CORIN USA                         510(k) NO: K131986(TRADITIONAL)
ATTN: LUCINDA  GERBER             PHONE NO : 813 977 4469   
5670 W. CYPRESS ST. SUITE C       SE DECISION MADE: 16-DEC-13
TAMPA FL 33607                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 2D PERFUSION
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K132147(ABBREVIATED)
ATTN: LISELOTTE  KORNMANN         PHONE NO : 31 611 621238
VEENPLUIS 4-6                     SE DECISION MADE: 16-DEC-13
BEST    NL 5684 PC                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RHYTHM VIEW WORKSTATION
TOPERA, INC.                      510(k) NO: K133305(SPECIAL)
ATTN: DENNIS  POZZO               PHONE NO : 314 300 6580   
3668 S. GEYER ROAD SUITE 365      SE DECISION MADE: 16-DEC-13
ST. LOUIS MO 63127   63127        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE
ETHICON ENDO-SURGERY, LLC         510(k) NO: K132522(TRADITIONAL)
ATTN: DAVID  LOCKE                PHONE NO : 513 337 1281   
4545 CREEK ROAD                   SE DECISION MADE: 16-DEC-13
CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONOSITE EDGE ULTRASOUND SYSTEM
FUJIFILM SONOSITE,INC.            510(k) NO: K133454(TRADITIONAL)
ATTN: PATRICIA  LIAU              PHONE NO : 425 951 6870   
21919 30th Dr SE                  SE DECISION MADE: 16-DEC-13
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT
CONSENSUS ORTHOPEDICS, INC.       510(k) NO: K130652(TRADITIONAL)
ATTN: MATTHEW  HULL               PHONE NO : 916 355 7156   
1115 WINDFIELD WAY STE 100        SE DECISION MADE: 17-DEC-13
EL DORADO HILLS CA 95762          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
HELIX MEDICAL, LLC                510(k) NO: K130736(TRADITIONAL)
ATTN: THOMAS M VASSALLO           PHONE NO : 805 576 5444   
1110 MARK AVE.                    SE DECISION MADE: 17-DEC-13
CARPINTERIA CA 93013              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS
ISORAY, INC                       510(k) NO: K132996(TRADITIONAL)
ATTN: FREDRIC  SWINDLER           PHONE NO : 509 375 1202   
350 Hills Street  Suite 106       SE DECISION MADE: 17-DEC-13
RICHLAND WA 99354                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERFIX ILIAC SCREW SYSTEM
U & I CORPORATION                 510(k) NO: K132218(TRADITIONAL)
ATTN: YOUNG-GEUN  KIM             PHONE NO : 82 31852 0102 X619
20, SANDAN-RO, 76BEON-GIL (RD)    SE DECISION MADE: 17-DEC-13
UIJEONGBU-SI, GYEONGGI-DO    KS 48510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOLL EPCR IOS
ZOLL MEDICAL CORPORATION          510(k) NO: K131919(SPECIAL)
ATTN: SHANNON  DUHAMEL            PHONE NO : 978 421 9574   
269 MILL ROAD                     SE DECISION MADE: 17-DEC-13
CHELMSFORD MA 01824 4105          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
ERBE USA, INC.                    510(k) NO: K132340(TRADITIONAL)
ATTN: JOHN  TARTAL                PHONE NO : 
2225 NORTHWEST PKWY.              SE DECISION MADE: 17-DEC-13
MARIETTA GA 30067                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL
STRYKER SPINE                     510(k) NO: K133188(SPECIAL)
ATTN: SORAYA  KING                PHONE NO : 201 760 8296   
2 PEARL COURT                     SE DECISION MADE: 17-DEC-13
ALLENDALE NJ 07401                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER DISTAL RADIUS PLATING SYSTEM
ZIMMER, INC.                      510(k) NO: K133246(TRADITIONAL)
ATTN: ROMIL  SHETH                PHONE NO : 574 371 1621   
P.O BOX 708                       SE DECISION MADE: 17-DEC-13
WARSAW IN 46581                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)
ALDEN OPTICAL LABS., INC.         510(k) NO: K133079(TRADITIONAL)
ATTN: KEVIN  RANDALL              PHONE NO : 303 828 0844   
16576 W. 53RD  WAY                SE DECISION MADE: 17-DEC-13
GOLDEN CO 80403                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTION ELITE VENA CAVA FILTER SYSTEM
REX MEDICAL LP                    510(k) NO: K133243(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 516 829 0451   
55 NORTHERN BLVD. SUITE 200       SE DECISION MADE: 17-DEC-13
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ST360 DEGREES SPINAL FIXATION SYSTEM
ZIMMER SPINE, INC                 510(k) NO: K133291(TRADITIONAL)
ATTN: MICHELLE  LENZ              PHONE NO : 952 830 6243   
7375 BUSH LAKE RD.                SE DECISION MADE: 17-DEC-13
MINNEAPOLIS MN 55441              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRIMADO2 TOTAL SURGICAL SYSTEM
NAKANISHI, INC.                   510(k) NO: K132264(TRADITIONAL)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480 9554   
1201 RICHARDSON DRIVE SUITE 280   SE DECISION MADE: 17-DEC-13
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX IBALANCE TKA SYSTEM
ARTHREX, INC.                     510(k) NO: K133342(SPECIAL)
ATTN: MARIELA  CABARCAS           PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 17-DEC-13
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALERE INFLUENZA A & B TEST
ALERE SCARBOROUGH, INC D/B/A BINAX510(k) NO: K133637(SPECIAL)
ATTN: ANGELA  DRYSDALE            PHONE NO : 207 730 5737   
10 Southgate Rd                   SE DECISION MADE: 18-DEC-13
Scarborough ME 04074              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EARLYSENSE
EARLYSENSE LTD.                   510(k) NO: K131379(TRADITIONAL)
ATTN: DALIA  ARGAMAN              PHONE NO : 972 3 7522330106
12 TZVI ST                        SE DECISION MADE: 18-DEC-13
RAMAT-GAN    IS 52504             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUCO HYBRID OSA APPLIANCE
LUCO HYBRID OSA APPLIANCE INC.    510(k) NO: K130797(TRADITIONAL)
ATTN: KEN  LUCO                   PHONE NO : 613 544 6019
1419 BUTTERNUT CREEK ROAD         SE DECISION MADE: 18-DEC-13
KINGSTON, ONTARIO    CA K7L 5H6   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TI STAR IMPLANT SYSTEM
T-PLUS IMPLANT TECH. CO., LTD.    510(k) NO: K132992(TRADITIONAL)
ATTN: DANA  CHENG                 PHONE NO : 886 222981 950
NO. 41, WUQUAN 6TH RD. WUGU DIST.,SE DECISION MADE: 18-DEC-13
NEW TAIPEI CITY    TW 248         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COPRA TEMP PMMA-DISK
WHITE PEAKS DENTAL SYSTEMS GMBH & 510(k) NO: K131664(TRADITIONAL)
ATTN: JOHN  WATERS                PHONE NO : 502 634 5357   
361 FARMINGTON AVENUE             SE DECISION MADE: 18-DEC-13
LOUISVILLE KY 40217               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M.U.S.T. EXTENSION
MEDACTA INTERNATIONAL             510(k) NO: K132878(TRADITIONAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 322 3289   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 18-DEC-13
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGEN U
POLLOGEN LTD                      510(k) NO: K131758(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202 637 5794   
555 THIRTEENTH ST, NW             SE DECISION MADE: 18-DEC-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
ROCHE DIAGNOSTICS                 510(k) NO: K132418(TRADITIONAL)
ATTN: KHOA  TRAN                  PHONE NO : 317 521 3409   
9115 HAGUE ROAD                   SE DECISION MADE: 18-DEC-13
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
OPTOMED OY                        510(k) NO: K132186(TRADITIONAL)
ATTN: JYRI  LESKELA, QUALITY MANAGPHONE NO : 358 40 8309507
Hallituskatu 13-17 D              SE DECISION MADE: 18-DEC-13
Oulu    FI 90100                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARIX HAND LOCKING SYSTEM
JEIL MEDICAL CORPORATION          510(k) NO: K132876(TRADITIONAL)
ATTN: HYEROUNG  LEE               PHONE NO : 82 285035 00
#702, KOLON SCIENCE VALLEY 2ND 811SE DECISION MADE: 18-DEC-13
SEOUL-CITY    KS 152-050          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APTUS CANNULATED COMPRESSION SCREWS
MEDARTIS AG                       510(k) NO: K133460(TRADITIONAL)
ATTN: ALLISON  KOMIYAMA           PHONE NO : 858 792 1235   
12264 EL CAMINO REAL, STE 400     SE DECISION MADE: 18-DEC-13
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION
STRYKER TRAUMA AG                 510(k) NO: K133440(SPECIAL)
ATTN: ELIJAH  WREH                PHONE NO : 201 831 5691   
325 CORPORATE DRIVE               SE DECISION MADE: 18-DEC-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISI MOBILE MONITIORING SYSTEM
SOTERA WIRELESS, INC              510(k) NO: K133586(SPECIAL)
ATTN: EBEN  GORDON                PHONE NO : 858 373 4841   
9444 WAPLES STREET SUITE 280      SE DECISION MADE: 18-DEC-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELISIO-H HEMODIALYZER
NIPRO MEDICAL CORPORATION         510(k) NO: K131381(SPECIAL)
ATTN: CAROLYN  GEORGE             PHONE NO : 678 947 3429   
6695 RIVER CREST PT               SE DECISION MADE: 19-DEC-13
SUWANEE GA 30024                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: YOUNG AGAIN
ESPANSIONE MARKETING SPA          510(k) NO: K124064(TRADITIONAL)
ATTN: GUIDO  BONAPACE             PHONE NO : 393 355378 686
VIA ALTOBELLI BONETTI 3A          SE DECISION MADE: 19-DEC-13
IMOLA(BO)    IT 40026             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOFTVUE
DELPHINUS MEDICAL TECHNOLOGIES, IN510(k) NO: K123209(TRADITIONAL)
ATTN: ANDREA N WALLEN             PHONE NO : 734 306 1069   
46701 COMMERCE CENTER DRIVE       SE DECISION MADE: 19-DEC-13
PLYMOUTH MI 48170                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE
XERIDIEM MEDICAL DEVICES          510(k) NO: K130611(TRADITIONAL)
ATTN: MICHELLE  LOTT              PHONE NO : 520 882 7794   
4700 S Overland Dr                SE DECISION MADE: 19-DEC-13
TUCSON AZ 85714                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ON CALL EXPRESS BLOOD  GLUCOSE MONITORING SYSTEM
ACON LABORATORIES, INC.           510(k) NO: K132086(TRADITIONAL)
ATTN: QIYI  XIE                   PHONE NO : 858 875 8011   
10125 Mesa Rim Road               SE DECISION MADE: 19-DEC-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LP(A) CALIBRATORS, AND LP(A) CONTROLS
BIOKIT S.A.                       510(k) NO: K132400(ABBREVIATED)
ATTN: JOAN  GUIXER                PHONE NO : 34 93 8609000
CAN MALE, S/N                     SE DECISION MADE: 19-DEC-13
LLISSA D'AMUNT, BARCELONA    SP 08510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
MICROVENTION, INC.                510(k) NO: K132952(SPECIAL)
ATTN: LARAINE  PANGELINA          PHONE NO : 714 247 8150   
1311 VALENCIA AVE                 SE DECISION MADE: 19-DEC-13
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE
MEDTRONIC                         510(k) NO: K132623(TRADITIONAL)
ATTN: MONICA  HERNANDEZ-SOTO      PHONE NO : 707 591 2285   
3576 UNOCAL PL                    SE DECISION MADE: 19-DEC-13
SANTA ROSA CA 95403               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LINA POWERBLADE PLUS
LINA MEDICAL APS                  510(k) NO: K132837(TRADITIONAL)
ATTN: CHRISTINE E NICHOLS         PHONE NO : 508 351 8632   
386 WEST MAIN ST. SUITE 7         SE DECISION MADE: 19-DEC-13
NORTHBOROUGH MA 01532             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VAPOR CERAMIC BRACKET
ORTHODONTIC DESIGN AND PRODUCTION,510(k) NO: K132368(TRADITIONAL)
ATTN: RICHARD  MERRELL            PHONE NO : 760 734 3995   
1370 DECISION STREET SUITE D      SE DECISION MADE: 19-DEC-13
VISTA CA 92081                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTVEST AIRWAY CLEARANCE SYSTEM
ELECTROMED, INC.                  510(k) NO: K132794(SPECIAL)
ATTN: CHET  SIEVERT               PHONE NO : 952 758 0384   
502 SIXTH AVE. N.W.               SE DECISION MADE: 19-DEC-13
NEW PRAGUE MN 56071               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025)
JVC KENWOOD CORPORATION           510(k) NO: K133511(TRADITIONAL)
ATTN: TSUKASA  TASHIRO            PHONE NO : 81 25824 6611
3-12, MORIYACHO, KANAGAWA-KU      SE DECISION MADE: 19-DEC-13
YOKOHAMA-SHI, KANAGAWA    JA 221-0510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
NEXXT SPINE LLC                   510(k) NO: K133475(SPECIAL)
ATTN: ERIC  LINTULA               PHONE NO : 317 436 7801   
14425 BERGEN BLVD SUITE B         SE DECISION MADE: 19-DEC-13
NOBLESVILLE IN 46060              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHYSOFT AMS
PHYSICIANS SOFTWARE SYSTEMS, LLC  510(k) NO: K130579(TRADITIONAL)
ATTN: LEWIS A MITCHELL            PHONE NO : 630 717 8192   
3333 WARRENVILLE ROAD SUITE 200   SE DECISION MADE: 19-DEC-13
LISLE IL 60532                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPRESSOR NEBULIZER MODEL MCN-S600XX
DONGGUAN AIDISY MACHINERY & ELECTR510(k) NO: K123030(TRADITIONAL)
ATTN: LEON  LU                    PHONE NO : 877 202 1588   
3500 SOUTH DUPONT HIGHWAY         SE DECISION MADE: 19-DEC-13
DOVER DE 19901                    510(k) STATEMENT

DEVICE: SMARTLOG DIABETES MANAGEMENT SOFTWARE
I-SENS, INC.                      510(k) NO: K133346(SPECIAL)
ATTN: HYE  YOUNG KANG             PHONE NO : 82 2916 6191
27-36 GWANGUN-RO, NOWON-GU        SE DECISION MADE: 19-DEC-13
SEOUL, KOREA    KS 139-845        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH
ANGIODYNAMICS, INC.               510(k) NO: K133561(SPECIAL)
ATTN: LORRAINE M HANLEY           PHONE NO : 508 494 1129   
603 QUEENSBURY AVE.               SE DECISION MADE: 19-DEC-13
QUEENSBURY NY 12804               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTRONIC PULSE MASSAGER
GURIN PRODUCTS, LLC               510(k) NO: K131933(TRADITIONAL)
ATTN: SANJAY  GUPTA               PHONE NO : 888 666 1557   
2522 CHAMBERS ROAD SUITE 100      SE DECISION MADE: 20-DEC-13
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTROTHERAPY DEVICE (COMBO UNIT)
GUANGZHOU FINECURE MEDICAL EQUIPME510(k) NO: K130691(TRADITIONAL)
ATTN: FIELD  FU                   PHONE NO : 867 558606 9197
05C.FUHAI KANGLE BUILDING NASHAN DSE DECISION MADE: 20-DEC-13
SHENZHEN    CH 518000             510(k) STATEMENT

DEVICE: BERNOULLI ENTERPRISE SOFTWARE
CARDIOPULMONARY CORP.             510(k) NO: K130208(TRADITIONAL)
ATTN: UREY  KANG                  PHONE NO : 800 337 9936   
200 CASCADE BLVD.                 SE DECISION MADE: 20-DEC-13
MILFORD CT 06460                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OCULAR FORCE GAUGE
OCULAR THERAPEUTIX, INC.          510(k) NO: K132917(TRADITIONAL)
ATTN: ERIC  ANKERUD               PHONE NO : 978 302 9467   
36 Crosby Dr Ste 101              SE DECISION MADE: 20-DEC-13
Bedford MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER
NIPRO MEDICAL CORPORATION         510(k) NO: K131935(SPECIAL)
ATTN: CAROLYN  GEORGE             PHONE NO : 678 947 3429   
3150 N.W. 107TH AVE.              SE DECISION MADE: 20-DEC-13
MIAMI FL 33172                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS
BAUSCH & LOMB INCORPORATED        510(k) NO: K132715(TRADITIONAL)
ATTN: JENNIFER  KNICLEY           PHONE NO : 585 338 6307   
1400 NORTH GOODMAN ST.            SE DECISION MADE: 20-DEC-13
ROCHESTER NY 14609                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TONE-A-MATIC
TONE-A-MATIC INTERNATIONAL, INC.  510(k) NO: K130052(TRADITIONAL)
ATTN: ANNIA  KORDIUK              PHONE NO : 905 501 0457   
145 TRADERS BLVD, EAST, UNIT 18   SE DECISION MADE: 20-DEC-13
MISSISSAUGA, ONTARIO    CA L4Z-3L3510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
CONMED CORPORATION                510(k) NO: K131765(TRADITIONAL)
ATTN: LISA  ANDERSON              PHONE NO : 315 624 3217   
525 FRENCH RD.                    SE DECISION MADE: 20-DEC-13
UTICA NY 13502                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUNETICS CLINICAL BIO-STIMULATION LASER
SUNETICS INTERNATIONAL MARKETING G510(k) NO: K132646(TRADITIONAL)
ATTN: JOHN  CARULLO               PHONE NO : 214 683 0724   
892 STEGER TOWNE RD  #44          SE DECISION MADE: 20-DEC-13
ROCKWALL TX 75032                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMAGE1 SPIES
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K131953(TRADITIONAL)
ATTN: WINKIE  WONG                PHONE NO : 424 218 8379   
2151 E. Grand Avenue              SE DECISION MADE: 20-DEC-13
El Segundo CA 90245               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARLE TISSUE ADHESIVE 2
ADVANCED MEDICAL SOLUTIONS (PLYMOU510(k) NO: K132243(TRADITIONAL)
ATTN: KAY  MCGRATH                PHONE NO : 44 160686 3500
WESTERN WOOD WAY LANGAGE SCIENCE PSE DECISION MADE: 20-DEC-13
PLYMOUTH, DEVON    UK PL7 5BG     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEAL BIOPSY VALVE - SEMI-DISPOSABLE
ENDOCHOICE, INC.                  510(k) NO: K132776(TRADITIONAL)
ATTN: DANIEL  HOEFER              PHONE NO : 678 708 4743   
11810 WILLS ROAD                  SE DECISION MADE: 20-DEC-13
ALPHARETTA GA 30009               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K-ETCHANT SYRINGE; NEEDLE TIP (E)
KURARAY NORITAKE DENTAL INC.      510(k) NO: K133078(TRADITIONAL)
ATTN: MICHIO  TAKIGAWA            PHONE NO : 813 670 11706
OTE CENTER BLDG 7F 1-1-3, OTEMACHISE DECISION MADE: 20-DEC-13
CHIYODA-KU    JA 100-0004         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V SERIES MONITORING SYSTEM, 12.1" DCU/V12 AND 21.0" DCU/V21
MINDRAY DS USA, INC.              510(k) NO: K132026(ABBREVIATED)
ATTN: RUSSELL  OLSEN              PHONE NO : 201 995 8391   
800 MACARTHUR BLVD                SE DECISION MADE: 20-DEC-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
DATEX-OHMEDA, INC.                510(k) NO: K132530(TRADITIONAL)
ATTN: JAMES P RASKOB              PHONE NO : 608 221 1551   
3030 Ohmeda Dr                    SE DECISION MADE: 20-DEC-13
MADISON WI 53718                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WANDY SELF-ADHESIVE ELECTRODES
WANDY RUBBER INDUSTRIAL CO., LTD  510(k) NO: K132998(TRADITIONAL)
ATTN: JACK  YI                    PHONE NO : 886 2 26943185
NO. 48 LANE 392, FU TEH 1ST RD    SE DECISION MADE: 20-DEC-13
NEW TAIPEI CITY    TW 221         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX)
COVIDIEN, FORMERLY VALLEYLAB, A DI510(k) NO: K133338(TRADITIONAL)
ATTN: DONALD  HENTON              PHONE NO : 303 530 6451   
5920 Longbow Dr                   SE DECISION MADE: 20-DEC-13
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEOTRACT UROLIFT SYSTEM
NEOTRACT, INC.                    510(k) NO: K133281(SPECIAL)
ATTN: NANCY E ISAAC               PHONE NO : 650 269 2552   
4473 WILLOW ROAD SUITE 100        SE DECISION MADE: 20-DEC-13
PLEASANTON CA 94588               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IDEAL
JIANGSU IDEAL MEDICAL SCIENCE & TE510(k) NO: K132428(TRADITIONAL)
ATTN: GONG  BO                    PHONE NO : 86 21 64957283
503 ROOM, 8 BLDG, 600 LIU ZHOU ROASE DECISION MADE: 20-DEC-13
SHANGHAI    CH 200233             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLYDIMETHYLSILOXANE IMPRESSION MATERIAL
BLACKWELL DEVICE CONSULTING       510(k) NO: K131510(TRADITIONAL)
ATTN: ANGELA  BLACKWELL           PHONE NO : 704 498 4059   
104 2ND STREET SE                 SE DECISION MADE: 20-DEC-13
CATAWBA NC 28609                  510(k) STATEMENT

DEVICE: STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM
STRYKER CORPORATION               510(k) NO: K132671(TRADITIONAL)
ATTN: MICHELLE  JUMP              PHONE NO : 269 389 3549   
4100 E. MILHAM AVE                SE DECISION MADE: 20-DEC-13
KALAMAZOO MI 49001                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMARC FIDUCIAL MARKER
CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K132708(TRADITIONAL)
ATTN: ANDREW J ADAMS              PHONE NO : 651 653 8512   
1290 HAMMOND RD.                  SE DECISION MADE: 20-DEC-13
ST. PAUL MN 55110                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTI ANGLED ABUTMENT SYSTEM
HIOSSEN INC.                      510(k) NO: K132067(SPECIAL)
ATTN: PATRICK  LIM                PHONE NO : 888 678 0001   
85 BEN FAIRLESS DRIVE             SE DECISION MADE: 20-DEC-13
FAIRLESS HILLS PA 19030           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIA MICROCATHETER, VIA PLUS MICROCATHETER
SEQUENT MEDICAL, INC              510(k) NO: K132652(TRADITIONAL)
ATTN: MELANIE  PARRAVI            PHONE NO : 949 830 9600   
11A COLUMBIA                      SE DECISION MADE: 20-DEC-13
ALISO VIEJO CA 92656              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KC 300 SURGICAL MASK
KIMBERLY-CLARK CORP.              510(k) NO: K131879(TRADITIONAL)
ATTN: MONICA  KING                PHONE NO : 770 587 7362   
1400 HOLCOMB BRIDGE RD.           SE DECISION MADE: 20-DEC-13
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIR BARRIER SYSTEM (ABS)
NIMBIC SYSTEMS, INC               510(k) NO: K123006(TRADITIONAL)
ATTN: HARVEY  KNAUSS              PHONE NO : 832 675 9281   
11874 SOUTH EVELYN CIRCLE         SE DECISION MADE: 20-DEC-13
HOUSTON TX 77477 3404             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRFIT N10
RESMED LTD.                       510(k) NO: K132887(TRADITIONAL)
ATTN: JIM  CASSI                  PHONE NO : 858 836 6081   
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 20-DEC-13
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MESO TENDON MATRIX
KENSEY NASH CORPORATION DBA DSM BI510(k) NO: K133169(TRADITIONAL)
ATTN: BRIANNA  JORDAN             PHONE NO : 484 713 2100   
735 PENNSYLVANIA DRIVE            SE DECISION MADE: 20-DEC-13
EXTON PA 19341                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOVIS PREOPERATIVE PLAN
CUSTOM ORTHOPAEDIC SOLUTIONS      510(k) NO: K133367(TRADITIONAL)
ATTN: JUSTIN  BAKER               PHONE NO : 216 445 2164   
10000 CEDAR AVE                   SE DECISION MADE: 20-DEC-13
CLEVELAND OH 44106                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE
VOLCANO CORPORATION               510(k) NO: K133641(SPECIAL)
ATTN: MARCUS  GARCIA              PHONE NO : 978 439 3312   
1 FORTUNE DR                      SE DECISION MADE: 20-DEC-13
BILLERICA MA 01821                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTI-STAGE SNARE
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K133513(SPECIAL)
ATTN: CARROLL  MARTIN             PHONE NO : 440 639 4494   
5976 HEISELY RD.                  SE DECISION MADE: 20-DEC-13
MENTOR OH 44060                   510(k) STATEMENT

DEVICE: AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
MICROVENTION, INC.                510(k) NO: K133626(SPECIAL)
ATTN: LARAINE  PANGELINA          PHONE NO : 714 247 8150   
1311 VALENCIA AVE                 SE DECISION MADE: 20-DEC-13
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
BOSTON SCIENTIFIC CORP.           510(k) NO: K133566(SPECIAL)
ATTN: MAYLIN  TRUESDELL           PHONE NO : 763 255 0877   
ONE SCIMED PLACE                  SE DECISION MADE: 20-DEC-13
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REST ASSURED EXTRA COMFORT NITE PROTECTOR
RANIR LLC                         510(k) NO: K133423(SPECIAL)
ATTN: PAULA  BOJSEN               PHONE NO : 616 698 8880   
4701 EAST PARIS AVE. S.E.         SE DECISION MADE: 20-DEC-13
Grand Rapids MI 49512             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XVWEB
APTERYX, INC.                     510(k) NO: K132342(TRADITIONAL)
ATTN: KEVIN  CRUCS                PHONE NO : 330 376 0889   
313 S HIGH ST. SUITE 200          SE DECISION MADE: 20-DEC-13
Akron OH 44308                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIVATOPIC PLUS
NIVAGEN PHARMACEUTICALS INC.      510(k) NO: K132329(TRADITIONAL)
ATTN: LARA  NOAH                  PHONE NO : 803 831 7657   
248 LATITUDE LANE, STE 104        SE DECISION MADE: 20-DEC-13
LAKE WYLIE SC 29710               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATHASSIST LIGHT SEEKER
ENTELLUS MEDICAL, INC.            510(k) NO: K133563(SPECIAL)
ATTN: GARRETT P AHLBORG           PHONE NO : 763 463 7074   
3600 HOLLY LANE NORTH, SUITE 40   SE DECISION MADE: 20-DEC-13
PLYMOUTH MN 55447                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM
NUVASIVE, INC.                    510(k) NO: K133052(TRADITIONAL)
ATTN: OLGA  LEWIS                 PHONE NO : 858 320 5257   
7475 LUSK BLVD                    SE DECISION MADE: 20-DEC-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM
BARD PERIPHERAL VASCULAR, INC.    510(k) NO: K133569(SPECIAL)
ATTN: TIFFINI  DIAGE              PHONE NO : 707 799 6732   
1307 SOUTH MARY AVENUE SUITE 280  SE DECISION MADE: 20-DEC-13
SUNNYVALE CA 94087                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPSTONE SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K133650(SPECIAL)
ATTN: GREGORY  MASCHEK            PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 20-DEC-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFIX ANTERIOR LUMBAR SYSTEM
ZIMMER SPINE, INC                 510(k) NO: K132790(TRADITIONAL)
ATTN: DONNA  SEMLAK               PHONE NO : 952 857 5643   
7375 BUSH LAKE RD.                SE DECISION MADE: 20-DEC-13
MINNEAPOLIS MN 55441              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300
ST. JUDE MEDICAL SYSTEMS AB       510(k) NO: K133587(SPECIAL)
ATTN: ERDULFO  DE PERALTA         PHONE NO : 978 577 3481   
4 ROBBINS RD.                     SE DECISION MADE: 20-DEC-13
WESTFORD MA 01886                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GMK SHORT STEM
MEDACTA INTERNATIONAL             510(k) NO: K133630(SPECIAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 910 6511   
1556 W CARROLL AVE                SE DECISION MADE: 20-DEC-13
CHICAGO IL 60607                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LAURIMED POLYPVAC MICRODEBRIDER
LAURIMED LLC                      510(k) NO: K133133(TRADITIONAL)
ATTN: NANCY  LINCE, RAC           PHONE NO : 650 759 6186   
8 CROW CANYON COURT, STE 205      SE DECISION MADE: 23-DEC-13
SAN RAMON CA 94583                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIPIFLOW THERMAL PULSATION SYSTEM
TEARSCIENCE, INC.                 510(k) NO: K133127(TRADITIONAL)
ATTN: CHRISTY  STEVENS, OD, MPH   PHONE NO : 919 459 4816   
5151 MCCRIMMON PARKWAY SUITE 250  SE DECISION MADE: 23-DEC-13
MORRISVILLE NC 27560              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2
3B MEDICAL, INC                   510(k) NO: K131901(TRADITIONAL)
ATTN: ALEX  LUCIO                 PHONE NO : 863 226 6285   
21301 HWY 27 N                    SE DECISION MADE: 23-DEC-13
Lake Wales FL 33859               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOTALSHIELD SURGICAL HELMET SYSTEM
ZIMMER, INC.                      510(k) NO: K132386(TRADITIONAL)
ATTN: ALLISON  SCOTT, RAC         PHONE NO : 317 569 9500   
9001 WESLEYAN ROAD, STE 200       SE DECISION MADE: 23-DEC-13
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
KEELER LTD.                       510(k) NO: K131787(SPECIAL)
ATTN: EUGENE R VANARSDALE         PHONE NO : 610 353 4350   
456 PARKWAY                       SE DECISION MADE: 23-DEC-13
BROOMALL PA 19008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASCOT
BACKROADS CONSULTING, INC.        510(k) NO: K132310(TRADITIONAL)
ATTN: KAREN E WARDEN, PHD         PHONE NO : 440 729 8457   
P.O. BOX 566                      SE DECISION MADE: 23-DEC-13
CHESTERLAND OH 44026 2141         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
COOPERVISION, INC.                510(k) NO: K133627(SPECIAL)
ATTN: ANNETTE  NELSON             PHONE NO : 925 621 2453   
6150 STONERIDGE MALL ROAD SUITE 37SE DECISION MADE: 23-DEC-13
PLEASANTON CA 94588               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
FOGLESS INTERNATIONAL AB          510(k) NO: K122932(TRADITIONAL)
ATTN: JASON  WALTON               PHONE NO : 460 361 44100
STORGATAN 24                      SE DECISION MADE: 23-DEC-13
VAGGERYD    SW 56732              510(k) STATEMENT

DEVICE: SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
COOK, INC.                        510(k) NO: K133634(SPECIAL)
ATTN: SEAN  SPENCE                PHONE NO : 812 335 3575   
750 DANIELS WAY                   SE DECISION MADE: 23-DEC-13
Blmgtn IN 47404                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED
CURE MEDICAL LLC.                 510(k) NO: K132500(SPECIAL)
ATTN: JOHN  BEASLEY               PHONE NO : 612 889 5168   
257 GARNET GARDEN STREET          SE DECISION MADE: 23-DEC-13
HENDERSON NV 89015                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
YUNG SHENG OPTICAL CO., LTD.      510(k) NO: K132854(TRADITIONAL)
ATTN: WEN-HAN  CHEN               PHONE NO : 886 425658 384
3F-1, NO. 6, JHONGKE ROAD, DAYA DISE DECISION MADE: 23-DEC-13
TAICHUNG CITY    TW 42881         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOZEC - RX PTCA BALLOON DILATATION CATHETER
MERIL LIFE SCIENCES PRIVATE LIMITE510(k) NO: K131169(TRADITIONAL)
ATTN: H. SEMIH  OKTAY             PHONE NO : 410 271 2088   
5523 RESEARCH PARK DR., SUITE 360 SE DECISION MADE: 24-DEC-13
BALTIMORE MD 21228                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM
IMPLANT DIRECT SYBRON MANUFACTURIN510(k) NO: K130572(TRADITIONAL)
ATTN: INES  ARAVENA               PHONE NO : 818 444 3300   
27030 Malibu Hills Rd             SE DECISION MADE: 24-DEC-13
Calabasas CA 91301                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
ABBOTT DIABETES CARE INC.         510(k) NO: K132511(SPECIAL)
ATTN: VRUSAHLI  TEMBE             PHONE NO : 510 864 4487   
1360 SOUTH LOOP RD.               SE DECISION MADE: 24-DEC-13
ALAMEDA CA 94502                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SWABCAP AND SWABFLUSH
EXCELSIOR MEDICAL CORP.           510(k) NO: K130975(TRADITIONAL)
ATTN: MICHAEL  HEYL               PHONE NO : 202 637 5456   
555 13TH STREET, NW               SE DECISION MADE: 24-DEC-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIGNIFY BIOACTIVE
GLOBUS MEDICAL INC.               510(k) NO: K130977(TRADITIONAL)
ATTN: SARAH MARIE  FITZGERALD     PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 24-DEC-13
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS
PHILIPS LIGHTING COMPANY          510(k) NO: K130519(TRADITIONAL)
ATTN: JAMES R CYRE                PHONE NO : 785 822 1511   
3861 SOUTH 9TH STREET             SE DECISION MADE: 24-DEC-13
SALINA KS 67401                   510(k) STATEMENT

DEVICE: ACUSON
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K131164(TRADITIONAL)
ATTN: SHELLY  PEARCE              PHONE NO : 650 694 5988   
1230 SHOREBIRD WAY                SE DECISION MADE: 24-DEC-13
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VELOX ANTERIOR CERVICAL PLATE SYSTEM
SPINECRAFT LLC                    510(k) NO: K131521(TRADITIONAL)
ATTN: AMI  AKALLAL-ASAAD          PHONE NO : 630 920 7300   
777 OAKMONT LANE                  SE DECISION MADE: 24-DEC-13
WESTMONT IL 60559                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTUITION - TDA, TVA, PARAMETRIC MAPPING
TERARECON, INC.                   510(k) NO: K131447(TRADITIONAL)
ATTN: EMILLY T NURTHEN            PHONE NO : 415 359 6032   
4000 E 3rd Ave Ste 200            SE DECISION MADE: 24-DEC-13
Foster City CA 94404              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COROENT STERILE IMPLANTS SYSTEM
NUVASIVE, INCORPORATED            510(k) NO: K132601(TRADITIONAL)
ATTN: OLGA  LEWIS                 PHONE NO : 858 320 5257   
7475 LUSK BOULEVARD               SE DECISION MADE: 24-DEC-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE
AAP IMPLANTATE AG                 510(k) NO: K132787(TRADITIONAL)
ATTN: CHRISTIAN  ZIETSCH          PHONE NO : 004 930 75019193
LORENZWEG 5                       SE DECISION MADE: 24-DEC-13
BERLIN    GM 12099                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
PIONEER SURGICAL TECHNOLOGY, INC  510(k) NO: K131724(TRADITIONAL)
ATTN: EMILY M DOWNS               PHONE NO : 906 225 5602   
375 RIVER PARK CIRCLE             SE DECISION MADE: 24-DEC-13
Marquette MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENUE 50
GE HEALTHCARE                     510(k) NO: K133431(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 INNOVATION DRIVE             SE DECISION MADE: 24-DEC-13
WAUWATOSA WI 53233                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARM AUTOMATIC BLOOD PRESSURE MONITOR
SHENZHEN PUMP MEDICAL SYSTEM CO., 510(k) NO: K130325(TRADITIONAL)
ATTN: IVY  CHEN                   PHONE NO : 086 075526 715351
KEJI NAN NO. 12 ROAD, HI-TECH PARKSE DECISION MADE: 24-DEC-13
SHENZHEN, GUANGDONG    CH 518057  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROVISION MEDICAL MOTION SENSOR
NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K130570(TRADITIONAL)
ATTN: CHRISTINE  VERGELY          PHONE NO : 805 866 6999   
2225 Sperry Ave Suite 1000        SE DECISION MADE: 26-DEC-13
VENTURA CA 93003                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KINGTECH FOREHEAD THERMOMETER
KINGTECH ENTERPRISE, LTD.         510(k) NO: K133113(TRADITIONAL)
ATTN: KE MIN  JEN                 PHONE NO : 852 248 10188
70 TA CHUNEN PING ST., REGENT CENTSE DECISION MADE: 26-DEC-13
KWAI CHUNG, NEW TERRITORIES    HK 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KINGTECH DIGITAL THERMOMETER
KINGTECH ENTERPRISE, LTD.         510(k) NO: K133111(TRADITIONAL)
ATTN: KE-MIN  JEN                 PHONE NO : 852 248 10188
70 TA CHUNEN PING ST., REGENT CENTSE DECISION MADE: 26-DEC-13
KWAI CHUNG, NEW TERRITORIES    HK 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS
CANDELA CORP.                     510(k) NO: K133283(SPECIAL)
ATTN: SAM  WADE                   PHONE NO : 508 358 7400   
530 BOSTON POST ROAD              SE DECISION MADE: 26-DEC-13
WAYLAND MA 01778                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OLEA SPHERE
OLEA MEDICAL                      510(k) NO: K132095(TRADITIONAL)
ATTN: CAROLINE  LENE              PHONE NO : 011 33442 712420
93 AVENUE DES SORBIERS ZONE ATHELISE DECISION MADE: 26-DEC-13
LA CIOTAT    FR 13600             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE
NEOCOIL, LLC                      510(k) NO: K133422(ABBREVIATED)
ATTN: KATIE  GONZALEZ             PHONE NO : 262 347 1250   
N27 W23910A PAUL ROAD             SE DECISION MADE: 26-DEC-13
PEWAUKEE WI 53072                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REUNION RSA SHOULDER SYSTEM
HOWMEDICA OSTEONICS CORP          510(k) NO: K130895(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461   
325 CORPORATE DR.                 SE DECISION MADE: 27-DEC-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NXSTAGE 1.6M2 DIALYZER
NXSTAGE MEDICAL, INC.             510(k) NO: K131050(TRADITIONAL)
ATTN: NNAMDI  NWACHUKWU           PHONE NO : 978 332 8477   
350 Merrimack St                  SE DECISION MADE: 27-DEC-13
LAWRENCE MA 01843                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LASER-STIM
SHENZHEN DONGDIXIN TECHNOLOGY CO, 510(k) NO: K131259(TRADITIONAL)
ATTN: JIANGPING  KANG             PHONE NO : 86 755276 52471
XILIXIAOBAIMANG                   SE DECISION MADE: 27-DEC-13
SHENZHEN, GUANGDONG    CH 518108  510(k) STATEMENT

DEVICE: EASY-LOAD LENS DELIVERY SYSTEM
BAUSCH & LOMB                     510(k) NO: K132481(TRADITIONAL)
ATTN: JASON  SMITH                PHONE NO : 800 393 6642   
30 ENTERPRISE SUITE 450           SE DECISION MADE: 27-DEC-13
ALISO VIEJO CA 92656 7115         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CEREBRALOGIK- AEEG
MENNEN MEDICAL LTD.               510(k) NO: K131789(TRADITIONAL)
ATTN: IFAT  SHWARTS               PHONE NO : 972 893233 3213
4 HAYARDEN ST., YAVNE P.O.BOX 102 SE DECISION MADE: 27-DEC-13
REHOVOT    IS 76100               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REU
STERICYCLE, INC.                  510(k) NO: K132007(TRADITIONAL)
ATTN: LORI  ADELS                 PHONE NO : 408 400 0856   
755 N. MATHILDA AVE., SUITE 100   SE DECISION MADE: 27-DEC-13
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
SAMSUNG MEDISON CO., LTD          510(k) NO: K133505(TRADITIONAL)
ATTN: PARK  KYEONG-MI             PHONE NO : 822 2194 1373
42, TEHERAN-RO 108-GIL            SE DECISION MADE: 27-DEC-13
GANGNAM-GU, SEOUL    KS 135-280   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MONUMENT SPACERS
GLOBUS MEDICAL INC.               510(k) NO: K132559(TRADITIONAL)
ATTN: CHRISTINA  KICHULA          PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 30-DEC-13
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM
CAYENNE MEDICAL, INC.             510(k) NO: K132867(TRADITIONAL)
ATTN: SHIMA  HASHEMIAN            PHONE NO : 480 502 3661   
16597 N. 92ND STREET SUITE 101    SE DECISION MADE: 30-DEC-13
SCOTTSDALE AZ 85260               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPRESSYN STAPLE
DALLEN MEDICAL, INC.              510(k) NO: K132875(TRADITIONAL)
ATTN: AL  MEMMOLO                 PHONE NO : 949 218 0030   
1046 Calle Recodo Ste G           SE DECISION MADE: 30-DEC-13
San Clemente CA 92673             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISUM BLADE LED SURGICAL LIGHTING SYSTEM
STRYKER COMMUNICATIONS            510(k) NO: K132747(TRADITIONAL)
ATTN: TREY  THORSEN               PHONE NO : 972 410 7181   
1410 LAKESIDE PKWY., #100         SE DECISION MADE: 30-DEC-13
FLOWER MOUND TX 75028             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLIQ DV-300 ASPIRATOR
DING HWA CO., LTD.                510(k) NO: K132308(TRADITIONAL)
ATTN: ROBERT O DEAN               PHONE NO : 716 440 7362   
1083 DELAWARE AVENUE              SE DECISION MADE: 30-DEC-13
BUFFALO NY 14209                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: G-SCAN BRIO
ESAOTE S.P.A.                     510(k) NO: K133490(SPECIAL)
ATTN: ALLISON S COTT              PHONE NO : 317 569 9500   
9001 WESLEYAN ROAD SUITE 200      SE DECISION MADE: 30-DEC-13
INDIANAPOLIS IN 46268   46268     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
THE ANSPACH EFFORT, INC.          510(k) NO: K131053(TRADITIONAL)
ATTN: ANNETTE M HILLRING          PHONE NO : 813 505 1555   
3012 ST. CHARLES DRIVE            SE DECISION MADE: 31-DEC-13
TAMPA FL 33618                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROCESSED DILATING TIP TROCARS
STRYKER SUSTAINABILITY SOLUTIONS  510(k) NO: K132629(TRADITIONAL)
ATTN: AMANDA  BABCOCK             PHONE NO : 888 888 3433   
1810 WEST DRAKE DRIVE             SE DECISION MADE: 31-DEC-13
TEMPE AZ 85283                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NASAL EASE ALLERGY BLOCKER
HI-TECH PHARMACAL, INC.           510(k) NO: K132520(TRADITIONAL)
ATTN: GARY  APRIL                 PHONE NO : 631 789 8228   
369 BAYVIEW AVE                   SE DECISION MADE: 31-DEC-13
AMITYVILLE NY 11701               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNBALLOON NON-OCCLUSION MODELING CATHETER
LEMAITRE VASCULAR, INC.           510(k) NO: K133026(TRADITIONAL)
ATTN: ANDREW  HODGKINSON          PHONE NO : 781 221 2266   
63 2ND AVENUE                     SE DECISION MADE: 31-DEC-13
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K133081(SPECIAL)
ATTN: KAZUNORI  MIYAHARA          PHONE NO : 310 533 9966   
3203 KASHIWA STREET               SE DECISION MADE: 31-DEC-13
TORRANCE CA 90505                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M1 CAPNOGRAPHY MASK
MONITOR MASK, INC.                510(k) NO: K133806(TRADITIONAL)
ATTN: STUART R GOLDMAN            PHONE NO : 512 327 9997   
816 CONGRESS AVENUE, SUITE 1400   SE DECISION MADE: 31-DEC-13
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW


                                                 TOTAL 510(k)s THIS PERIOD   287                                     
                                                 TOTAL WITH SUMMARIES        272                                     
                                                 TOTAL WITH STATEMENTS        15