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U.S. Department of Health and Human Services

Medical Devices

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April 2013 510(k) Clearances

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


DEVICE: NMI COAXIAL MICROINTRODUCER SET
NAVILYST MEDICAL, INC.            510(k) NO: K123445(TRADITIONAL)
ATTN: WANDA  CARPINELLA           PHONE NO : 508 263 9714   
26 FOREST STREET                  SE DECISION MADE: 01-APR-13
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER
THE BINDING SITE GROUP LTD        510(k) NO: K120056(TRADITIONAL)
ATTN: JILL  CONSTANTINE           PHONE NO : 440 121 4569500
8 CALTHORPE ROAD EDGBASTON        SE DECISION MADE: 01-APR-13
BIRMINGHAM, WEST MIDLANDS    UK B1510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM
MEDTRONIC INC.                    510(k) NO: K123733(TRADITIONAL)
ATTN: KARI  CHRISTIANSON          PHONE NO : 763 514 9529   
8200 CORAL SEA STREET NE MS MVS83 SE DECISION MADE: 01-APR-13
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WALKAIDE SYSTEM
INNOVATIVE NEUROTRONICS INC.      510(k) NO: K123972(TRADITIONAL)
ATTN: GLEN  NEALLY                PHONE NO : 512 721 1903   
3600-B N. CAPITAL OF TEXAS HWY SUISE DECISION MADE: 01-APR-13
AUSTIN TX 78746 3211              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IFUSE IMPLANT SYSTEM
SI-BONE, INC.                     510(k) NO: K123850(SPECIAL)
ATTN: CINDY  DOMECUS              PHONE NO : 650 343 4813   
1171 BARROILHET DR                SE DECISION MADE: 01-APR-13
HILLSBOROUGH CA 94010             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STREAMLINE MIS SPINAL FIXATION SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC  510(k) NO: K130286(TRADITIONAL)
ATTN: EMILY M DOWNS               PHONE NO : 906 225 5602   
375 RIVER PARK CIRCLE             SE DECISION MADE: 01-APR-13
Marquette MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFINITY TOTAL ANKLE SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K123954(TRADITIONAL)
ATTN: SAMIR  IBRAHIM              PHONE NO : 901 867 9971   
5677 AIRLINE RD.                  SE DECISION MADE: 01-APR-13
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPIDER SYSTEM KOLIBRI CEMENT NEEDLE
SINTEA PLUSTEK, LLC               510(k) NO: K130402(SPECIAL)
ATTN: RICH  JANSEN                PHONE NO : 612 281 5505   
13540 GUILD AVE                   SE DECISION MADE: 01-APR-13
APPLE VALLEY MN 55124             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROBLATE SYSTEM
MONTERIS MEDICAL, INC.            510(k) NO: K120561(TRADITIONAL)
ATTN: JEFF  WILSON                PHONE NO : 204 272 2220
100 - 78 Innovation Drive         SE DECISION MADE: 01-APR-13
Winnipeg    CA R3T 6C2            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K123906(TRADITIONAL)
ATTN: CLAIRE  EVANS               PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 01-APR-13
Memphis TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANS1LATERAL INTERBODY FUSION SYSTEM
TRANS1, INC.                      510(k) NO: K123997(TRADITIONAL)
ATTN: CHERYL L WAGONER            PHONE NO : 910 332 1700   
301 GOVERNMENT CENTER DR          SE DECISION MADE: 01-APR-13
WILMINGTON NC 28403               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMECATH DUAL LUMEN HEMODIALYSIS CATHETER
AMECO MEDICAL INDUSTRIES          510(k) NO: K123943(TRADITIONAL)
ATTN: RAY  KELLY                  PHONE NO : 203 880 4091   
ARAZY GROUP 57 LAZY BROOK RD.     SE DECISION MADE: 02-APR-13
MONROE CT 03468                   510(k) STATEMENT

DEVICE: THERMOFINDER; THERMOCARE
HUBDIC CO., LTD                   510(k) NO: K130361(SPECIAL)
ATTN: MATT  HANSEN                PHONE NO : 516 279 7207   
504 BLUEGRASS DRIVE               SE DECISION MADE: 02-APR-13
CANONSBURG PA 15317               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: INMODE SR IPL DEVICE
INMODE MD LTD.                    510(k) NO: K123860(TRADITIONAL)
ATTN: AHAVA  STEIN                PHONE NO : 972 9 7670002
20 HATA'AS STR., SUITE 102        SE DECISION MADE: 02-APR-13
KFAR SABA    IS 44425             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXCELSIOR
EYEKOR, LLC.                      510(k) NO: K130453(TRADITIONAL)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 02-APR-13
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTUITION
TERARECON, INC.                   510(k) NO: K121916(TRADITIONAL)
ATTN: ROBERT  TAYLOR              PHONE NO : 415 577 9036   
4000 E 3rd Ave Ste 200            SE DECISION MADE: 02-APR-13
Foster City CA 94404              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD MAX CDIFF ASSAY, BD MAX INSTRUMENT
GENEOHM SCIENCES CANADA, INC. (BD 510(k) NO: K130470(TRADITIONAL)
ATTN: PATRICIA  DIONNE            PHONE NO : 418 780 7783
2555 Boul. du Parc-Technologique  SE DECISION MADE: 02-APR-13
Quebec    CA G1P 4S5              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO.CT NEURO PERFUSION
SIEMENS MEDICAL SYSTEMS, INC.     510(k) NO: K123541(TRADITIONAL)
ATTN: KIMBERLY  MANGUM            PHONE NO : 610 448 4912   
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 02-APR-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS
BOSSONG HOSIERY MILLS, INC        510(k) NO: K123820(TRADITIONAL)
ATTN: ROGER  RAND                 PHONE NO : 828 327 2551   
3855 8TH STREET PLACE NW          SE DECISION MADE: 02-APR-13
HICKORY NC 28601                  510(k) STATEMENT

DEVICE: TANDA MINI SKINCARE SYSTEM
SYNERON BEAUTY                    510(k) NO: K124042(SPECIAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET ST., 29TH FLOOR       SE DECISION MADE: 02-APR-13
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CELSITE IMPLANTABLE ACCESS PORT SYSTEMS
B. BRAUN INTERVENTIONAL SYSTEMS IN510(k) NO: K130576(SPECIAL)
ATTN: AMBER  KINGSTON             PHONE NO : 610 997 4459   
3100 W Lake St Ste 420            SE DECISION MADE: 02-APR-13
Minneapolis MN 55416              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER IVAS BALLOON CATHETER
STRYKER CORPORATION               510(k) NO: K123942(TRADITIONAL)
ATTN: CHRISTINA  MCKEE            PHONE NO : 
4100 E. MILHAM AVE                SE DECISION MADE: 03-APR-13
KALAMAZOO MI 49001                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS
THE LAGADO CORP.                  510(k) NO: K130285(TRADITIONAL)
ATTN: ELLEN M BEUCLER             PHONE NO : 978 658 6888   
187 BALLARDVALE STREET SUITE 180  SE DECISION MADE: 03-APR-13
WILMINGTON MA 01887               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR
NP MEDICAL, INC.                  510(k) NO: K130023(TRADITIONAL)
ATTN: ROBERT J BARD, JD, RAC, CQE PHONE NO : 248 573 5040   
PO BOX 506                        SE DECISION MADE: 03-APR-13
SOUTH LYON MI 48178               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK
PORTABLE THERAPEUTIX, LLC         510(k) NO: K123829(TRADITIONAL)
ATTN: SHARYN  ORTON               PHONE NO : 401 330 8264   
200 HOMER AVE.                    SE DECISION MADE: 03-APR-13
ASHLAND MA 01721                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPEQRT ULTRASOUND SYSTEM
SIGNOSTICS PTY LTD                510(k) NO: K130659(TRADITIONAL)
ATTN: VARDA  SWERY                PHONE NO : 61 8 81529400
LOT 1, 40-46 WEST THEBARTON RD    SE DECISION MADE: 03-APR-13
THEBARTON SA    AS 5031           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K130423(TRADITIONAL)
ATTN: RON  HASELHORST             PHONE NO : 847 913 1113   
353 CORPORATE WOODS PKWY.         SE DECISION MADE: 03-APR-13
VERNON HILLS IL 60061             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCULIF XL CAGE
COALIGN INNOVATIONS, INC.         510(k) NO: K130194(SPECIAL)
ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   
1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 03-APR-13
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHANTOM FIBER BIOFIBER SUTURE
TORNIER, INC.                     510(k) NO: K130422(SPECIAL)
ATTN: LAEL J PICKETT              PHONE NO : 612 219 7350   
10801 NESBITT AVENUE              SE DECISION MADE: 04-APR-13
BLOOMINGTON MN 55437              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYSTEROSCOPY PUMP HM6
W.O.M. WORLD OF MEDICINE AG       510(k) NO: K123732(SPECIAL)
ATTN: SUSANNE  RAAB               PHONE NO : 617 547 0628   
1480 CAMBRIDGE STREET             SE DECISION MADE: 04-APR-13
CAMBRIDGE MA 02139                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K122194(TRADITIONAL)
ATTN: ROBERT  TU                  PHONE NO : 886 226 620038
3 FL., NO. 5, LANE 155, SEC.3, PEISE DECISION MADE: 04-APR-13
SHEN KENG HSIANG,TAIPEI HSIEN    T510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
NOVA BIOMEDICAL CORPORATION       510(k) NO: K122688(TRADITIONAL)
ATTN: PAUL W MACDONALD            PHONE NO : 781 894 0800   
200 Prospect St                   SE DECISION MADE: 04-APR-13
WALTHAM MA 02454                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS
ECKERT & ZIEGLER BEBIG GMBH       510(k) NO: K123263(ABBREVIATED)
ATTN: HUB  VAN DE BERGH           PHONE NO : 31 62 3135698
MUURZWALUW 30                     SE DECISION MADE: 04-APR-13
VEENENDAAL    NL 3905RZ           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KCI NPWT GAUZE DRESSING
KCI USA, INC.                     510(k) NO: K123507(TRADITIONAL)
ATTN: ANONA  GOEBEL               PHONE NO : 210 255 6345   
6203 FARINON DR.                  SE DECISION MADE: 04-APR-13
SAN ANTONIO TX 78249              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE 2000 ANTI-CCP IGG ASSAY
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K121576(TRADITIONAL)
ATTN: SUSAN  BROCCHI              PHONE NO : 914 524 2525   
511 BENEDICT AVE.                 SE DECISION MADE: 04-APR-13
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AGILITY
ELEKTA LTD.                       510(k) NO: K123808(TRADITIONAL)
ATTN: PATRICK  HULL               PHONE NO : 44 129365 4165
FLEMING WAY LINAC HOUSE           SE DECISION MADE: 04-APR-13
CRAWLEY, WEST SUSSEX    UK RH10 9R510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II
ELITECHGROUP                      510(k) NO: K130765(ABBREVIATED)
ATTN: DEBRA K HUTSON              PHONE NO : 425 482 5174   
21720 23RD DR SE SUITE 150        SE DECISION MADE: 04-APR-13
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIAISON FTA LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3
DIASORIN, INC.                    510(k) NO: K121951(TRADITIONAL)
ATTN: KELLY R SAUER               PHONE NO : 651 351 5884   
1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 04-APR-13
STILLWATER MN 55082 0285          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEARLAB ACA
FRYE ELECTRONICS, INC.            510(k) NO: K123701(TRADITIONAL)
ATTN: KRISTINA  FRYE              PHONE NO : 503 620 2722   
9826 S.W. TIGARD ST.              SE DECISION MADE: 05-APR-13
TIGARD OR 97223                   510(k) STATEMENT

DEVICE: 6.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEM
OCO BIOMEDICAL                    510(k) NO: K122198(TRADITIONAL)
ATTN: JACK  BLOOM                 PHONE NO : 505 293 0025   
9550 SAN MATEO BLVD NE, SUITE -C  SE DECISION MADE: 05-APR-13
ALBUQUERQUE NM 87113              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MERIT HYDROPHILIC GUIDE WIRE
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K130588(SPECIAL)
ATTN: MARTHA  FOLAN               PHONE NO : 353 91703 7000(3168)
PARKMORE BUSINESS PARK WEST       SE DECISION MADE: 05-APR-13
GALWAY    EI EI                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX FRACTURE PLATES
ARTHREX, INC.                     510(k) NO: K123241(TRADITIONAL)
ATTN: COURTNEY  SMITH             PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 05-APR-13
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY
ORTHOCON, INC.                    510(k) NO: K123243(TRADITIONAL)
ATTN: HOWARD  SCHRAYER            PHONE NO : 914 357 2600   
1 BRIDGE STREET, SUITE 121        SE DECISION MADE: 05-APR-13
IRVINGTON NY 10533                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY
INDUSTRIAL CLOTHINGS, LTD.        510(k) NO: K122453(TRADITIONAL)
ATTN: S.N.  HARI                  PHONE NO : 943 654 22200
D 17, SEETHAWAKA EXPORT PROCESSINGSE DECISION MADE: 05-APR-13
AUISSAWELLA    CE 10700           510(k) STATEMENT

DEVICE: HEALTHY SLEEP APPLIANCE
HEALTHY SLEEP DENTAL LABORATORY   510(k) NO: K123410(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DR.                SE DECISION MADE: 05-APR-13
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEURO OMEGA SYSTEM
ALPHA OMEGA ENGINEERING LTD.      510(k) NO: K123796(TRADITIONAL)
ATTN: ILAN  SHARON                PHONE NO : 972 528704 904
PO BOX 4414 (A109)                SE DECISION MADE: 05-APR-13
CAESAREA    IS 30889              510(k) STATEMENT

DEVICE: SENTREX BIOSPONGE MPD
BIONOVA MEDICAL, INC              510(k) NO: K123961(TRADITIONAL)
ATTN: ALEX  GREENE                PHONE NO : 901 748 2581   
3011 CENTRE OAK WAY SUITE 102     SE DECISION MADE: 05-APR-13
GERMANTOWN TN 38138               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CIQ CONTROLLER, CIQ WANDS
ARTHROCARE CORPORATION            510(k) NO: K123353(TRADITIONAL)
ATTN: MITCHELL  DHORITY           PHONE NO : 512 358 5995   
7000 West William Cannon Drive    SE DECISION MADE: 05-APR-13
Austin TX 78735                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS
COOK BIOTECH INCORPORATED         510(k) NO: K130006(TRADITIONAL)
ATTN: NICK X WANG                 PHONE NO : 765 497 3355   
1425 INNOVATION PLACE             SE DECISION MADE: 05-APR-13
WEST LAFAYETTE IN 47906           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMPLI SIMPLER IMPLANT SYSTEM
SIMPLER IMPLANT SOLUTIONS         510(k) NO: K121281(ABBREVIATED)
ATTN: HAROLD  BERGMAN             PHONE NO : 604 736 9890
No. 404, 1023 WOLFE AVE           SE DECISION MADE: 05-APR-13
VANCOUVER    CA V6H1V6            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K130698(ABBREVIATED)
ATTN: ANNA MARIE  ENNIS           PHONE NO : 302 631 9352   
500 GBC DRIVE                     SE DECISION MADE: 05-APR-13
NEWARK DE 19702                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
COVIDIEN                          510(k) NO: K130744(SPECIAL)
ATTN: DIANE  REED                 PHONE NO : 303 581 7093   
5920 LONGBOW DR.                  SE DECISION MADE: 05-APR-13
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3
DIASORIN, INC.                    510(k) NO: K130469(TRADITIONAL)
ATTN: KELLY  SAUER                PHONE NO : 651 351 5884   
1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 05-APR-13
STILLWATER MN 55082 0285          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM
BIOCARE CORPORATION               510(k) NO: K122307(TRADITIONAL)
ATTN: SHUCHI  CHANG               PHONE NO : 886 326 16678
4F, NO.12, LANE 5, SEC. 2 NASHAN RSE DECISION MADE: 05-APR-13
TAOYUAN COUNTY    TW 33852        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PONTIC PAINT
RELIANCE ORTHODONTIC PRODUCTS, INC510(k) NO: K130237(TRADITIONAL)
ATTN: PAULA  WENDLAND             PHONE NO : 630 773 4009   
1540 WEST THORNDALE AVE.          SE DECISION MADE: 05-APR-13
ITASCA IL 60143                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
CLEVELAND CLINIC                  510(k) NO: K123122(TRADITIONAL)
ATTN: STEPHEN J PEOPLES, VMD, MS  PHONE NO : 260 645 0327   
10000 CEDAR AVENUE                SE DECISION MADE: 05-APR-13
CLEVELAND OH 44106                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM
HITACHI ALOKA MEDICAL, LTD.       510(k) NO: K130308(SPECIAL)
ATTN: ANGELA  VANARSDALE          PHONE NO : 203 269 5088   
10 FAIRFIELD BLVD.                SE DECISION MADE: 05-APR-13
WALLINGFORD CT 06492 7502         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP
MAPA GMBH                         510(k) NO: K121478(TRADITIONAL)
ATTN: MARK  WOZNIAK               PHONE NO : 608 524 5916   
728 BOOSTER BLVD.                 SE DECISION MADE: 05-APR-13
REEDSBURG WI 53959                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIBROSCAN
ECHOSENS                          510(k) NO: K123806(TRADITIONAL)
ATTN: ZVI  LADIN, PH.D.           PHONE NO : 781 407 0900   
990 WASHINGTON STREET, STE #204   SE DECISION MADE: 05-APR-13
DEDHAM MA 02026                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISOLATOR LINEAR PEN
ATRICURE, INC.                    510(k) NO: K130521(SPECIAL)
ATTN: REBECCA  WALTERS            PHONE NO : 513 755 4576   
6217 CENTRE PARK DRIVE            SE DECISION MADE: 05-APR-13
WEST CHESTER OH 45069             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCUMESH DEPLOYMENT SYSTEM
COVIDIEN LLC                      510(k) NO: K130782(SPECIAL)
ATTN: JOSE  MARQUEZ               PHONE NO : 781 839 1755   
15 CROSBY DRIVE                   SE DECISION MADE: 05-APR-13
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INNOVA EPVISION 2.0, INNOVA EPVISION 2.0
GE HEALTHCARE                     510(k) NO: K130069(TRADITIONAL)
ATTN: NING  WEN                   PHONE NO : 331 307056 68
283 RUE DE LA MINIERE             SE DECISION MADE: 05-APR-13
BUC    FR 78530                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K130044(TRADITIONAL)
ATTN: RYAN  BORMANN               PHONE NO : 901 867 4409   
5677 AIRLINE RD.                  SE DECISION MADE: 05-APR-13
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONSTER SCREW SYSTEM
APOGEE ORTHOSOLUTIONS             510(k) NO: K124027(TRADITIONAL)
ATTN: KAREN E WARDEN, PHD         PHONE NO : 440 729 8457   
PO BOX 566                        SE DECISION MADE: 05-APR-13
CHESTERLAND OH 44026 2141         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOCKING BONE PLATES AND SCREWS
WEIGAO ORTHOPAEDIC DEVICE CO., LTD510(k) NO: K130340(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
PO BOX 237-023                    SE DECISION MADE: 05-APR-13
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OLYMPUS ENERGY POWER SYSTEM (EPS)
GYRUS ACMI, INC.                  510(k) NO: K123429(TRADITIONAL)
ATTN: DOLAN  MILLS                PHONE NO : 901 373 0236   
136 TURNPIKE RD.                  SE DECISION MADE: 05-APR-13
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
ABBOTT LABORATORIES               510(k) NO: K123089(TRADITIONAL)
ATTN: DAVID G LAMBERT             PHONE NO : 510 749 5105   
1360 SOUTH LOOP ROAD              SE DECISION MADE: 05-APR-13
ALAMEDA CA 94502                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM
KINAMED, INC.                     510(k) NO: K122049(TRADITIONAL)
ATTN: HEATHER  NEELY              PHONE NO : 805 384 2748   
820 FLYNN RD.                     SE DECISION MADE: 05-APR-13
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MERETEC CS, CORTICAL SCREWS
MERETE MEDICAL GMBH               510(k) NO: K130400(SPECIAL)
ATTN: EMMANUEL  ANAPLIOTIS        PHONE NO : 49 307799 80114
102 ALT LANKWITZ                  SE DECISION MADE: 05-APR-13
BERLIN    GM D-12247              510(k) STATEMENT

DEVICE: MEPILEX TRANSFER AG
MOLNLYCKE HEALTH CARE             510(k) NO: K123892(TRADITIONAL)
ATTN: ANGELA L BUNN, RAC          PHONE NO : 678 250 7930   
5550 PEACHTREE PARKWAY SUITE 500  SE DECISION MADE: 05-APR-13
NORCROSS GA 30092                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OTOMAG BONE CONDUCTION HEARING SYSTEM
SOPHONO, INC                      510(k) NO: K123962(TRADITIONAL)
ATTN: KRISTA B TRAYNOR            PHONE NO : 720 407 5160   
5744 CENTRAL AVENUE #100          SE DECISION MADE: 08-APR-13
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XP200
BTL INDUSTRIES LTD                510(k) NO: K122966(TRADITIONAL)
ATTN: RICHARD  VINCINS            PHONE NO : 512 326 9997   
611 WEST 5TH STREET THIRD FLOOR   SE DECISION MADE: 08-APR-13
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INCORIS ZI
SIRONA DENTAL SYSTEMS GMBH        510(k) NO: K123664(TRADITIONAL)
ATTN: FRITZ  KOLLE                PHONE NO : 496 251163 294
FABRIKSTRASSE 31                  SE DECISION MADE: 08-APR-13
BENSHEIM    GM D-64625            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EUROIMMUN ANTI-ENA POOL ELISA (IGG)
EUROIMMUN US                      510(k) NO: K112996(TRADITIONAL)
ATTN: KATHRYN  KOHL               PHONE NO : 973 656 1000   
1100 THE AMERICAN ROAD            SE DECISION MADE: 09-APR-13
MORRIS PLAINS NJ 07950            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM
BIO COMPRESSION SYSTEMS, INC.     510(k) NO: K122112(TRADITIONAL)
ATTN: MAUREEN  GARNER             PHONE NO : 732 779 7422   
1983 HAZELWOOD ROAD               SE DECISION MADE: 09-APR-13
TOMS RIVER NJ 08754               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WARMING JELLY PERSONAL LUBRICANT
WISCONSIN PHARMACAL CO., LLC      510(k) NO: K123770(TRADITIONAL)
ATTN: JOHN  NYGAARD               PHONE NO : 262 677 4121   
1 PHARMACAL WAY                   SE DECISION MADE: 09-APR-13
JACKSON WI 53037                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GORE ACUSEAL VASCULAR GRAFT
W.L. GORE & ASSOCIATES,INC        510(k) NO: K130215(TRADITIONAL)
ATTN: MICHAEL  IVEY               PHONE NO : 928 864 3790   
1505 NORTH FOURTH ST.             SE DECISION MADE: 09-APR-13
FLAGSTAFF AZ 86003 3000           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPSTONE L SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA       510(k) NO: K123978(TRADITIONAL)
ATTN: LAUREN  KAMER               PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 09-APR-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K123996(TRADITIONAL)
ATTN: MARY  CARTER                PHONE NO : 414 362 2626   
8200 WEST TOWER AVE.              SE DECISION MADE: 09-APR-13
Milwaukee WI 53223                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEVON CIRONA 6100 DVT
DEVON MEDICAL INC.                510(k) NO: K130571(TRADITIONAL)
ATTN: RUTH  WU                    PHONE NO : 866 446 0092   
1100 1ST AVENUE SUITE 100         SE DECISION MADE: 09-APR-13
KING OF PRUSSIA PA 19406          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PSA SERIES
OSYPKA MEDICAL, INC.              510(k) NO: K123916(TRADITIONAL)
ATTN: MARKUS  OSYPKA              PHONE NO : 858 454 0021   
7855 IVANHOE AVE., SUITE 226      SE DECISION MADE: 09-APR-13
LA JOLLA CA 92037                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT
MEDTRONIC IRELAND                 510(k) NO: K123153(TRADITIONAL)
ATTN: DEIRDRE  MCMAHON            PHONE NO : 353 917089 68
PARKMORE BUSINESS PARK WEST       SE DECISION MADE: 09-APR-13
GALWAY    EI EL                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS
DIASORIN                          510(k) NO: K130321(TRADITIONAL)
ATTN: CAROL  DEPOUW               PHONE NO : 651 351 5711   
1951 NORTHWESTERN AVENUE PO BOX 28SE DECISION MADE: 09-APR-13
STILLWATER MN 55082 0285          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARFIL MAJESTY ES FLOW
KURARAY NORITAKE DENTAL INC.      510(k) NO: K130371(TRADITIONAL)
ATTN: MICHIO  TAKIGAWA            PHONE NO : 81 367011 706
OTE CENTER BLDG 7F 1-1-3, OTEMACHISE DECISION MADE: 09-APR-13
CHIYODA-KU    JA 100-0004         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNAPSE 3D CARDIAC TOOLS
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K130383(TRADITIONAL)
ATTN: JYH-SHYAN  LIN              PHONE NO : 301 251 1092   
419 WEST AVE.                     SE DECISION MADE: 09-APR-13
STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM
STRYKER                           510(k) NO: K123786(TRADITIONAL)
ATTN: JAMSHED  BADARPURA          PHONE NO : 269 389 4260   
750 TRADE CENTRE WAY STE 200      SE DECISION MADE: 09-APR-13
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K130665(SPECIAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 09-APR-13
GAITHERSBURG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINE COIL
USA PARAMED MEDICAL SYSTEMS, INC. 510(k) NO: K123708(TRADITIONAL)
ATTN: RICHARD  OLSON              PHONE NO : 847 470 0580   
6204 W. OAKTON ST.                SE DECISION MADE: 10-APR-13
MORTON GROVE IL 60053             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PENTAX EPK-I5010 VIDEO PROCESSOR
SCHIFF & COMPANY, INC.            510(k) NO: K122470(TRADITIONAL)
ATTN: ROBERT  SCHIFF              PHONE NO : 973 227 1830   
1129 BLOOMFIELD AVE.              SE DECISION MADE: 10-APR-13
WEST CALDWELL NJ 07006            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM
MEDRAD, INC.                      510(k) NO: K130637(SPECIAL)
ATTN: BRIT  BAIRD                 PHONE NO : 425 636 4137   
10801 120TH AVENUE NE             SE DECISION MADE: 10-APR-13
KIRKLAND WA 98033                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
HEALGEN SCIENTIFIC, LLC           510(k) NO: K123703(TRADITIONAL)
ATTN: BRYAN  FANG                 PHONE NO : 713 733 8088   
3818 FUQUA STREET                 SE DECISION MADE: 10-APR-13
HOUSTON TX 77401                  510(k) STATEMENT

DEVICE: ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085
XHALE                             510(k) NO: K122996(TRADITIONAL)
ATTN: DAVID  RICH                 PHONE NO : 860 616 1610   
701 HEBRON AVENUE                 SE DECISION MADE: 10-APR-13
GLASTONBURY CT 06033              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K130646(SPECIAL)
ATTN: BRAD  SHEALS                PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 10-APR-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRAUMANN DENTAL IMPLANT SYSTEM
STRAUMANN USA, LLC                510(k) NO: K123784(TRADITIONAL)
ATTN: JENNIFER M JACKSON, MS      PHONE NO : 978 747 2509   
60 MINUTEMAN ROAD                 SE DECISION MADE: 10-APR-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TK1 TOTAL KNEE SYSTEM
NOVOSOURCE INC                    510(k) NO: K123339(TRADITIONAL)
ATTN: JAMES  PINKSTON             PHONE NO : 435 774 1502   
124 SOUTH 600 WEST                SE DECISION MADE: 11-APR-13
LOGAN UT 84321                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTILASER SYSTEM
ULTRALIGHT LASER TECHNOLOGIES, LLC510(k) NO: K123777(TRADITIONAL)
ATTN: MARK  ROHRER                PHONE NO : 205 290 8251   
105 CITATION COURT                SE DECISION MADE: 11-APR-13
HOMEWOOD AL 35209                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAXX(R) IB SYSTEM
SPINE WAVE, INC.                  510(k) NO: K123461(TRADITIONAL)
ATTN: ROAIDA  RIZKALLAH           PHONE NO : 203 944 9494   
THREE ENTERPRISE DR. SUITE 210    SE DECISION MADE: 11-APR-13
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHORT PORT BLUNT TIP TROCAR
MAQUET CARDIOVASCULAR LLC         510(k) NO: K130121(TRADITIONAL)
ATTN: MARK  DINGER                PHONE NO : 973 709 7691   
45 BARBOUR POND DRIVE             SE DECISION MADE: 11-APR-13
Wayne NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING
ENCORE MEDICAL, L.P.              510(k) NO: K122239(TRADITIONAL)
ATTN: TEFFANY  HUTTO              PHONE NO : 512 832 9500   
9800 METRIC BLVD.                 SE DECISION MADE: 11-APR-13
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STORM MINI SCREW
LANCER ORTHODONTICS, INC.         510(k) NO: K122069(TRADITIONAL)
ATTN: LARRY  WALKER               PHONE NO : 760 304 2711   
2330 Cousteau Court               SE DECISION MADE: 11-APR-13
Vista CA 92081                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPIC 10S
BIOLASE TECHNOLOGY, INC.          510(k) NO: K130465(TRADITIONAL)
ATTN: COLLEEN  BOSWELL            PHONE NO : 949 226 8470   
4 CROMWELL                        SE DECISION MADE: 11-APR-13
IRVINE CA 92618 1816              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFINITY CENTRALSTATION WITH INFINITY M300
DRAEGER MEDICAL SYSTEMS, INC.     510(k) NO: K130711(SPECIAL)
ATTN: TOM  OSTROWSKI              PHONE NO : 978 379 8002   
6 TECH DRIVE                      SE DECISION MADE: 11-APR-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTREMITY MEDICAL IP FUSION SYSTEM
EXTREMITY MEDICAL, LLC            510(k) NO: K130120(TRADITIONAL)
ATTN: BRIAN  SMEKAL               PHONE NO : 973 588 8980   
300 Interpace Pkwy Ste 410        SE DECISION MADE: 11-APR-13
Parsippany NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
CAS MEDICAL SYSTEMS, INC.         510(k) NO: K123700(TRADITIONAL)
ATTN: RON  JEFFREY                PHONE NO : 203 488 6056   
44 EAST INDUSTRIAL RD.            SE DECISION MADE: 11-APR-13
BRANFORD CT 06405                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS
WUXI JIAJIAN MEDICAL INSTRUMENT CO510(k) NO: K122812(TRADITIONAL)
ATTN: DORIS  DONG                 PHONE NO : 86 21 31261348
ROOM 1706, NO.128 SONGLE RD SONGJISE DECISION MADE: 11-APR-13
SHANGHAI    CH 201600             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM
SYNTHES                           510(k) NO: K122455(TRADITIONAL)
ATTN: ANGELA F LASSANDRO          PHONE NO : 610 719 6854   
1301 GOSHEN PARKWAY               SE DECISION MADE: 11-APR-13
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALICOIL SUTURE ANCHOR WITH REGENESORB
SMITH & NEPHEW, INC.              510(k) NO: K123393(TRADITIONAL)
ATTN: SUE  DAHLQUIST              PHONE NO : 978 749 1000   
150 MINUTEMAN RD.                 SE DECISION MADE: 11-APR-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SINGLE USE PRELOADED SPHINCTEROTOME V
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K122505(TRADITIONAL)
ATTN: SHERI  MUSGNUNG             PHONE NO : 484 896 3147   
REGULATORY AFFAIRS & QUALITY ASSURSE DECISION MADE: 11-APR-13
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
MENTOR CORP.                      510(k) NO: K130813(SPECIAL)
ATTN: MARTIN  SPRUNCK             PHONE NO : 908 218 2651   
201 MENTOR DR.                    SE DECISION MADE: 11-APR-13
SANTA BARBARA CA 93111            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATIENT MONITOR
LD TECHNOLOGY LLC                 510(k) NO: K130056(TRADITIONAL)
ATTN: ALBERT  MAAREK              PHONE NO : 305 379 9900   
100 N. BISCAYNE BLVD, STE 502     SE DECISION MADE: 11-APR-13
MIAMI FL 33132                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASTELLE Q-SWITCHED ND: YAG LASER
WON TECHNOLOGY CO., LTD.          510(k) NO: K123293(TRADITIONAL)
ATTN: ROBERTA  HINES              PHONE NO : 425 481 8380   
24125 85TH AVE. SE                SE DECISION MADE: 11-APR-13
WOODINVILLE WA 98072              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S4 SPINAL SYSTEM
AESCULAP IMPLANT SYSTEM, INC.     510(k) NO: K130291(TRADITIONAL)
ATTN: LISA M BOYLE                PHONE NO : 610 984 9274   
3773 CORPORATE PARKWAY            SE DECISION MADE: 11-APR-13
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INCITE ANCHORED CERVICAL INTERBODY DEVICE
INCITE INNOVATION LLC             510(k) NO: K130306(SPECIAL)
ATTN: JOHN  KIRWAN                PHONE NO : 413 382 0212   
1500 MAIN STREET STE. 2410        SE DECISION MADE: 11-APR-13
SPRINGFIELD MA 01115              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IOLMASTER 500
CARL ZEISS MEDITEC AG             510(k) NO: K122418(TRADITIONAL)
ATTN: JUDITH A BRIMACOMBE         PHONE NO : 952 557 4616   
5160 HACIENDA DRIVE               SE DECISION MADE: 12-APR-13
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)
EUROIMMUN US                      510(k) NO: K113439(TRADITIONAL)
ATTN: KATHRYN  KOHL               PHONE NO : 973 656 1000   
1100 THE AMERICAN ROAD            SE DECISION MADE: 12-APR-13
MORRIS PLAINS NJ 07950            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRAMEDULLARY NAIL SYSTEM
WEIGAO ORTHOPAEDIC DEVICE CO., LTD510(k) NO: K122994(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122815 850
PO BOX 237-023                    SE DECISION MADE: 12-APR-13
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
ANDON MEDICAL CO., LTD.           510(k) NO: K123935(TRADITIONAL)
ATTN: YI  LIU                     PHONE NO : 86 22 87612426
NO.26 HANGYU RD. TIANJIN AIRPORT ESE DECISION MADE: 12-APR-13
TIANJIN    CH 300381              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMARC GOLD FIDUCIAL MARKER
CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K130678(SPECIAL)
ATTN: ANDREW J ADAMS              PHONE NO : 651 653 8512   
1290 Hammond Rd                   SE DECISION MADE: 12-APR-13
Saint Paul MN 55110               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE
INDUSTRIAL CLOTHINGS, LTD.        510(k) NO: K122464(TRADITIONAL)
ATTN: S.N.  HARI                  PHONE NO : 943 654 22200
D 17, SEETHAWAKA EXPORT PROCESSINGSE DECISION MADE: 12-APR-13
AUISSAWELLA    CE 10700           510(k) STATEMENT

DEVICE: XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION
GE MEDICAL SYSTEMS F.I. HAIFA     510(k) NO: K130884(TRADITIONAL)
ATTN: ELI  WERNER                 PHONE NO : 972 485636 66
4 HAYOZMA ST.                     SE DECISION MADE: 12-APR-13
TIRAT HACARMEL    IS 30200        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ZMED VP4000
ZMED, INC.                        510(k) NO: K130929(TRADITIONAL)
ATTN: RANDALL S MILLAR            PHONE NO : 858 831 7000   
9820 SUMMERS RIDGE RD             SE DECISION MADE: 12-APR-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO
PHILIPS MEDIZIN SYSTEME BOEBLINGEN510(k) NO: K122223(TRADITIONAL)
ATTN: MARKUS  STACHA              PHONE NO : 497 031 4632840
HEWLETT-PACKARD STR. 2            SE DECISION MADE: 12-APR-13
BOEBLINGEN    GM 71034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM
SAMSUNG MEDISON CO., LTD          510(k) NO: K130803(TRADITIONAL)
ATTN: KYEONG-MI  PARK             PHONE NO : 
42, TEHERAN-RO 108-GIL GANGNAM-GU SE DECISION MADE: 12-APR-13
SEOUL    KS                       510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: QUIKCLOT HEMOSTATIC DRESSING
Z-MEDICA, LLC                     510(k) NO: K123387(TRADITIONAL)
ATTN: SHEILA  WALLIN              PHONE NO : 203 294 0000   
4 FAIRFIELD BLVD.                 SE DECISION MADE: 12-APR-13
Wallingford CT 06492              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK
BIO-RAD LABORATORIES              510(k) NO: K130761(TRADITIONAL)
ATTN: SUZANNE  PARSONS            PHONE NO : 949 598 1467   
9500 JERONIMO RD.                 SE DECISION MADE: 12-APR-13
IRVINE CA 92618 2017              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APTUS HELI-FX AORTIC SECUREMENT SYSTEM
APTUS ENDOSYSTEMS, INC.           510(k) NO: K130677(SPECIAL)
ATTN: BURT  GOODSON               PHONE NO : 408 530 9050   
271 GIBRALTAR DRIVE               SE DECISION MADE: 12-APR-13
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0
HITACHI ALOKA MEDICAL,LTD. (HITACH510(k) NO: K122537(TRADITIONAL)
ATTN: RICHARD J CEHOVSKY          PHONE NO : 203 269 5088   
10 FAIRFIELD BLVD.                SE DECISION MADE: 12-APR-13
WALLINGFORD CT 06492 7502         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MICROSLIDER TEARAWAY INTRODUCER SET
GALT MEDICAL CORP.                510(k) NO: K123430(TRADITIONAL)
ATTN: DAVID  DERRICK              PHONE NO : 972 271 5177   
2220 MERRITT DR.                  SE DECISION MADE: 12-APR-13
GARLAND TX 75041                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
SONOSCAPE COMPANY LIMITED         510(k) NO: K130119(TRADITIONAL)
ATTN: TOKI  WU                    PHONE NO : 86 755 26722890
Yizhe Building, Yuquan Road, NanshSE DECISION MADE: 12-APR-13
SHENZHEN    CN 518051             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOSPA TOTAL KNEE REPLACEMENT SYSTEM
CORENTEC CO., LTD                 510(k) NO: K130673(SPECIAL)
ATTN: J.S.  DANIEL                PHONE NO : 82 074393 3819
8TH CHUNGHO TOWER, 748-1 BANPO 1 DSE DECISION MADE: 15-APR-13
SEOCHO GU, SEOUL    KN 137-040    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERSONAL HEALTH CENTER (PHC)
ADFLOW HEALTH NETWORKS INC        510(k) NO: K122076(TRADITIONAL)
ATTN: GLEN  FEYE                  PHONE NO : 619 517 1762   
3232 IBIS ST                      SE DECISION MADE: 15-APR-13
SAN DIEGO CA 92103                510(k) STATEMENT

DEVICE: VIVASIGHT-DL SYSTEM
ETVIEW LTD.                       510(k) NO: K123853(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 463888 37
31 HAAVODA ST.                    SE DECISION MADE: 15-APR-13
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTICROSS 40 MHZ CORONARY IMAGING CATHETER
BOSTON SCIENTIFIC CORP.           510(k) NO: K123621(TRADITIONAL)
ATTN: ERIC  ELLIOTT               PHONE NO : 510 624 1314   
47215 LAKEVIEW BOULEVARD          SE DECISION MADE: 15-APR-13
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AESCULAP CESPACE XP
AESCULAP IMPLANT SYSTEM, INC.     510(k) NO: K123909(TRADITIONAL)
ATTN: LISA M BOYLE                PHONE NO : 610 984 9274   
3773 CORPORATE PARKWAY            SE DECISION MADE: 15-APR-13
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
THE BINDING SITE GROUP, LTD.      510(k) NO: K122304(TRADITIONAL)
ATTN: JILL  CONSTANTINE           PHONE NO : 440 121 4569500
8 CALTHORPE ROAD WEST MIDLANDS    SE DECISION MADE: 15-APR-13
EDGBASTON    UK B15 1QT           510(k) STATEMENT

DEVICE: YOULASER CO2 LASER
QUANTA SYSTEM, S.P.A.             510(k) NO: K123573(TRADITIONAL)
ATTN: MAURIZIO  BIANCHI           PHONE NO : 390 331376 797
VIA IV NOVEMBRE,116               SE DECISION MADE: 15-APR-13
SOLBIATE OLONA    IT 21058        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Z CARTRIDGE IOL DELIVERY SYSTEM
AAREN SCIENTIFIC, INC             510(k) NO: K123888(TRADITIONAL)
ATTN: ROBERT K SHEEHAN            PHONE NO : 909 937 1033   
4290 E. BRICKELL ST. BLDG A       SE DECISION MADE: 15-APR-13
ONTARIO CA 91761                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PEERSCOPE SYSTEM
PEERMEDICAL LTD.                  510(k) NO: K130718(SPECIAL)
ATTN: TAMAR  FUERST               PHONE NO : 972 463 277731
2 HATOCHEN ST BUSINESS AND INDUSTRSE DECISION MADE: 16-APR-13
CAESAREA    IS 38900              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRIGADE STANDALONE SYSTEM
NUVASIVE, INC.                    510(k) NO: K123045(SPECIAL)
ATTN: CYNTHIA  ADAMS              PHONE NO : 858 320 4549   
7475 LUSK BLVD                    SE DECISION MADE: 16-APR-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIGN PEDIATRIC FIN NAIL
SIGN FRACTURE CARE INTERNATIONAL  510(k) NO: K122823(TRADITIONAL)
ATTN: DOUGLAS  DONNELLY           PHONE NO : 509 371 1107   
451 Hills St Ste B                SE DECISION MADE: 16-APR-13
RICHLAND WA 99354                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PAINMASTER MCT PATCH
NEWMARK, INC.                     510(k) NO: K130114(TRADITIONAL)
ATTN: CHERITA  JAMES              PHONE NO : 703 562 9800   
901 KING STREET SUITE 101         SE DECISION MADE: 16-APR-13
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VS3
VISIONSENSE, LTD.                 510(k) NO: K123467(SPECIAL)
ATTN: GERARD J PRUD'HOMME         PHONE NO : 202 637 5735   
555 13TH STREET, NW               SE DECISION MADE: 17-APR-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT
COVIDIEN                          510(k) NO: K123083(TRADITIONAL)
ATTN: STACEY A STRAND             PHONE NO : 303 305 2631   
6135 GUNBARREL AVE.               SE DECISION MADE: 17-APR-13
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,
INOVA DIAGNOSTICS, INC.           510(k) NO: K123593(TRADITIONAL)
ATTN: GABRIELLA  LAKOS            PHONE NO : 858 586 9900   
9900 OLD GROVE RD.                SE DECISION MADE: 17-APR-13
SAN DIEGO CA 92131 1638           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER
HEADSTAR MEDICAL PRODUCTS CO., LTD510(k) NO: K121770(TRADITIONAL)
ATTN: GLORIA  CHEN                PHONE NO : 886 285 217623
9 F., NO. 8, SEC. 1, CHUNG-SHAN ROSE DECISION MADE: 17-APR-13
CITY, TAIPEI COUNTY    TW 242     510(k) STATEMENT

DEVICE: MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.
COVIDIEN LP, FORMERLY REGISTERED A510(k) NO: K130725(SPECIAL)
ATTN: DOLLY  MISTRY               PHONE NO : 508 452 1646   
15 HAMPSHIRE ST.                  SE DECISION MADE: 17-APR-13
MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C
DIAMOND DIAGNOSTICS, INC.         510(k) NO: K124009(TRADITIONAL)
ATTN: KATHY  CRUZ                 PHONE NO : 508 429 0450   
333 FISKE ST.                     SE DECISION MADE: 17-APR-13
HOLLISTON MA 01746                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SLEEP PROFILER
ADVANCED BRAIN MONITORING, INC.   510(k) NO: K130007(TRADITIONAL)
ATTN: ADRIENNE  LENZ              PHONE NO : 262 290 0023   
W324 S3649 COUNTY RD E            SE DECISION MADE: 17-APR-13
DOUSMAN WI 53118                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSTAFLO BOWEL CATHETER SYSTEM KIT
HOLLISTER, INC.                   510(k) NO: K123804(TRADITIONAL)
ATTN: CHRIS  STUKEL               PHONE NO : 847 918 3452   
2000 HOLLISTER DR.                SE DECISION MADE: 17-APR-13
LIBERTYVILLE IL 60048             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLASMATRODE SALINE SAFE TUR ELECTRODE
COOK IRELAND LTD                  510(k) NO: K122716(TRADITIONAL)
ATTN: NORA  O'CONNOR              PHONE NO : 353 613 34440
O HALLORAN ROAD NATIONAL TECHNOLOGSE DECISION MADE: 17-APR-13
LIMERICK    IE 000                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUECPR COACHING DEVICE
PHYSIO-CONTROL, INC.              510(k) NO: K123597(TRADITIONAL)
ATTN: TERESA  DAVIDSON            PHONE NO : 425 867 4733   
11811 WILLOWS RD., N.E. PO BOX 970SE DECISION MADE: 17-APR-13
REDMOND WA 98073 9706             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LTN - LAPAROSCOPIC SURGICAL MESH
LIFECELL CORP.                    510(k) NO: K130817(SPECIAL)
ATTN: JOHN  BLEWITT               PHONE NO : 908 947 1432   
ONE MILLENNIUM WAY                SE DECISION MADE: 17-APR-13
BRANCHBURG NJ 08876               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION
AGAMATRIX INC                     510(k) NO: K130535(SPECIAL)
ATTN: WILLIAM H MCGRAIL           PHONE NO : 603 328 6051   
7C RAYMOND AVE                    SE DECISION MADE: 17-APR-13
SALEM NH 03079                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C350
PERMOBIL AB                       510(k) NO: K123290(TRADITIONAL)
ATTN: JAN  ASTROM                 PHONE NO : 004 660 595900
PER UDDENS VAG 20                 SE DECISION MADE: 17-APR-13
TIMRA    SW S-861 23              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRIVE DUAL ZONE PEAK FLOW METER
MONAGHAN MEDICAL CORP.            510(k) NO: K123945(TRADITIONAL)
ATTN: CARI J REIL                 PHONE NO : 518 561 7330   
5 LATOUR AVE., SUITE 1600         SE DECISION MADE: 17-APR-13
Plattsburgh NY 12901              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMINED STANDARD SOLUTION
MESA LABORATORIES, INC.           510(k) NO: K130100(TRADITIONAL)
ATTN: JAMIE  LOUIE                PHONE NO : 303 565 4846   
12100 W 6th Ave                   SE DECISION MADE: 18-APR-13
LAKEWOOD CO 80228                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MD211C3 21.3" DIAGNOSTIC IMAGING LCD MONITOR
NEC DISPLAY SOLUTIONS, LTD.       510(k) NO: K130770(TRADITIONAL)
ATTN: ANGUS  HSU                  PHONE NO : 886 22603 7288 X 218
1F, # 181, S. 2, WUNHUA 1ST RD LINSE DECISION MADE: 18-APR-13
TAIPEI    TW 24447                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MD211C2 21.3" DIAGNOSTIC IMAGING LCD MONITOR
NEC DISPLAY SOLUTIONS, LTD.       510(k) NO: K130772(TRADITIONAL)
ATTN: ANGUS  HSU                  PHONE NO : 886 22603 7288 X 218
1F, # 181, S. 2, WUNHUA 1ST RD LINSE DECISION MADE: 18-APR-13
TAIPEI    TW 24447                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: A3F FRATIONAL
POLLOGEN LTD                      510(k) NO: K122200(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 463 88837
31 HAAVODA ST.                    SE DECISION MADE: 18-APR-13
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDO GIA RELOAD
COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K130717(SPECIAL)
ATTN: KATHERINE  ROBERTSON        PHONE NO : 203 492 5299   
60 Middletown Ave                 SE DECISION MADE: 18-APR-13
North Haven CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREXION3D ECLIPSE
THE YOSHIDA DENTAL MFG. CO., LTD. 510(k) NO: K122199(TRADITIONAL)
ATTN: TOSHIMITSU  MURAKAMI        PHONE NO : 81 35 2972822
1-14-1 KANDASUDA-CHO FUNAI TOKYO TSE DECISION MADE: 18-APR-13
CHIYODA-KU, TOKYO    JA 101-0041  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RHYTHMIA MAPPING CATHETER
RHYTHMIA MEDICAL, INC             510(k) NO: K122461(TRADITIONAL)
ATTN: LEON  AMARIGLIO             PHONE NO : 617 591 9191   
111 SOUTH BEDFORD ST SUITE 205    SE DECISION MADE: 18-APR-13
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM
SPECTRAL MD, INC                  510(k) NO: K124049(TRADITIONAL)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480 9554   
1201 RICHARDSON DRIVE, SUITE 280  SE DECISION MADE: 18-APR-13
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPICAGE INTERBODY FUSION DEVICE
ALPHATEC SPINE, INC.              510(k) NO: K130548(SPECIAL)
ATTN: NADINE  SMITH               PHONE NO : 760 434 6717   
5818 EL CAMINO REAL               SE DECISION MADE: 18-APR-13
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
NEOSURGICAL LTD                   510(k) NO: K123280(TRADITIONAL)
ATTN: ORLA  BRENNAN               PHONE NO : 353 091 421000
BLOCK 12 GALWAY TECHNOLOGY PARK, PSE DECISION MADE: 18-APR-13
GALWAY    EI EI                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T
SEDECAL SA                        510(k) NO: K130883(TRADITIONAL)
ATTN: LUISA  GOMEZ DE AGUERO      PHONE NO : 
C/PELAYA, 9-13, POL. IND. RIO DE JSE DECISION MADE: 18-APR-13
ALGETE, MADRID    SP 28110        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
MAUNA KEA TECHNOLOGIES            510(k) NO: K123676(TRADITIONAL)
ATTN: MICHAEL  DANIEL             PHONE NO : 415 407 0223   
8 SNOWBERRY COURT                 SE DECISION MADE: 18-APR-13
ORINDA CA 94563                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)
ARCOS, INC.                       510(k) NO: K121659(TRADITIONAL)
ATTN: CHRIS  MEADOR               PHONE NO : 713 397 3030   
866 W. 41ST                       SE DECISION MADE: 18-APR-13
HOUSTON TX 77018                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYDRASOLVE LIPOPLASTY SYSTEM
ANDREW TECHNOLOGIES, LLC          510(k) NO: K130152(TRADITIONAL)
ATTN: HERBERT  CRANE              PHONE NO : 949 502 1907   
3 Haddon Avenue                   SE DECISION MADE: 18-APR-13
Haddonfield NJ 08033              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
PHILIPS MEDICAL SYSTEMS           510(k) NO: K123900(SPECIAL)
ATTN: MARY  KRUITWAGEN            PHONE NO : 978 659 4932   
3000 MINUTEMAN RD.                SE DECISION MADE: 18-APR-13
ANDOVER MA 01810 1099             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM
ITENA CLINICAL                    510(k) NO: K121804(ABBREVIATED)
ATTN: LOUIS  PAUL MARIN           PHONE NO : 514 928 5546
500 BOUL CARTIER WEST             SE DECISION MADE: 19-APR-13
LAVAL    CA H7V 5B7               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROFEMUR XM DISTAL CENTRALIZER
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K130167(TRADITIONAL)
ATTN: MATT  PAUL                  PHONE NO : 901 867 4350   
5677 AIRLINE RD.                  SE DECISION MADE: 19-APR-13
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FALLER STYLET
MEDIONICS INTERNATIONAL, INC.     510(k) NO: K130441(TRADITIONAL)
ATTN: MAHESH  AGARWAL             PHONE NO : 905 472654 4
114 ANDERSON AVE.                 SE DECISION MADE: 19-APR-13
MARKHAM, ONTARIO    CA L6E 1A5    510(k) STATEMENT

DEVICE: INSTINCT JAVA SYSTEM
ZIMMER SPINE                      510(k) NO: K123552(TRADITIONAL)
ATTN: ELSA A LINKE                PHONE NO : 952 830 6205   
7375 BUSH LAKE ROAD               SE DECISION MADE: 19-APR-13
EDINA MN 55439                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K122539(TRADITIONAL)
ATTN: STEVEN  GOLDBERG            PHONE NO : 781 269 3941   
2 EDGEWATER DRIVE                 SE DECISION MADE: 19-APR-13
NORWOOD MA 02062                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K130335(SPECIAL)
ATTN: RYAN  MASSEY                PHONE NO : 800 873 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 19-APR-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARCOS TROCHANTER BUTTON
BIOMET, INC.                      510(k) NO: K130063(SPECIAL)
ATTN: BECKY  EARL                 PHONE NO : 574 267 6639   
56 EAST BELL DR.                  SE DECISION MADE: 19-APR-13
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEWFIX EXTERNAL FIXATION SYSTEM
TECNOLOGIA Y DISENO INDUSTRIAL, S.510(k) NO: K122210(TRADITIONAL)
ATTN: ROBERT J BARD               PHONE NO : 248 573 5040   
PO BOX 506                        SE DECISION MADE: 19-APR-13
SOUTH LYON MI 48178               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC BIOSPHERER BIOACTIVE BONE GRAFT PUTTY, 5CC
SYNERGY BIOMEDICAL, LLC           510(k) NO: K122868(TRADITIONAL)
ATTN: RANDY  PREBULA              PHONE NO : 202 637 6548   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 19-APR-13
WASHINGTON DC 20009               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTRODE, FLEXIBLE SUCTION COAGULATOR
OPTIM, LLC.                       510(k) NO: K130489(SPECIAL)
ATTN: JEFF  BARRETT, CEO          PHONE NO : 508 556 5165   
64 TECHNOLOGY PARK RD.            SE DECISION MADE: 19-APR-13
STURBRIDGE MA 01566               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT
APPLIED MEDICAL TECHNOLOGY, INC.  510(k) NO: K123716(TRADITIONAL)
ATTN: GRANT W PHILLIPS            PHONE NO : 440 717 4000   
8000 KATHERINE BOULEVARD          SE DECISION MADE: 19-APR-13
BRECKSVILLE OH 44141              510(k) STATEMENT

DEVICE: ECAT SCINTRON PET
MIE GMBH                          510(k) NO: K130269(TRADITIONAL)
ATTN: THOMAS  KUEHL               PHONE NO : 49 419499 770
HAUPTSTRASSE 112                  SE DECISION MADE: 19-APR-13
SETH    GM D-23845                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS
XIAMEN DOUBLE ENGINE MEDICAL MATER510(k) NO: K130108(TRADITIONAL)
ATTN: DA  ZENG                    PHONE NO : 86 0592 6087078
NO. 218, HOUXIANG ROAD HAICANG DISSE DECISION MADE: 19-APR-13
XIAMEN    CH 361022               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIBRILLAR COLLAGEN WOUND DRESSING
COLLAFIRM LLC                     510(k) NO: K120250(TRADITIONAL)
ATTN: SURENDRA  BATRA             PHONE NO : 732 823 1051   
7 DEER PARK DRIVE SUITE M-7       SE DECISION MADE: 21-APR-13
MONMOUTH JUNCTION NJ 08852        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIODE LASER
BEIJING SYNTECH LASER CO., LTD.   510(k) NO: K123483(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 237-023                  SE DECISION MADE: 21-APR-13
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXXIS OR
BARCO NV                          510(k) NO: K122167(TRADITIONAL)
ATTN: LIEVEN  DE WANDEL           PHONE NO : 32 56 233459
35 PRESIDENT KENNEDYPARK          SE DECISION MADE: 22-APR-13
KORTRIJK    BE 8500               510(k) STATEMENT

DEVICE: NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)
VARIAN MEDICAL SYSTEMS, X-RAY PROD510(k) NO: K130318(SPECIAL)
ATTN: CATHERINE  MULCAHY          PHONE NO : 315 453 4550   
121 METROPOLITAN DR.              SE DECISION MADE: 22-APR-13
LIVERPOOL NY 13088                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK
STAYHEALTHY, INC.                 510(k) NO: K123539(TRADITIONAL)
ATTN: COLIN  HILL PHD.            PHONE NO : 626 256 6152   
24 EAST HUNGTINGTON DRIVE         SE DECISION MADE: 22-APR-13
MONROVIA CA 91016                 510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: XHIBIT CENTRAL STATION, MODEL 96102
SPACELABS HEALTHCARE              510(k) NO: K122146(TRADITIONAL)
ATTN: THOMAS  KROENKE             PHONE NO : 303 956 4232   
P.O. BOX 3018                     SE DECISION MADE: 22-APR-13
NEDERLAND CO 80466                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AAP CANNULATED SCREW 2.0
AAP IMPLANTATE AG                 510(k) NO: K130590(TRADITIONAL)
ATTN: CHRISTIAN  ZIETSCH          PHONE NO : 004 930 75019193
LORENZWEG 5                       SE DECISION MADE: 22-APR-13
BERLIN    GM 12099                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXFIN MODEL 2
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K122381(TRADITIONAL)
ATTN: MARGUERITE  THOMLINSON      PHONE NO : 949 756 4386   
ONE EDWARDS WAY                   SE DECISION MADE: 22-APR-13
IRVINE CA 92614                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ERCHONIA PL5000
ERCHONIA MEDICAL INC              510(k) NO: K130741(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
33 GOLDEN EAGLE LANE              SE DECISION MADE: 23-APR-13
LITTLETON CO 80127                510(k) STATEMENT

DEVICE: NXSTAGE SYSTEM ONE
NXSTAGE MEDICAL, INC.             510(k) NO: K122051(SPECIAL)
ATTN: MARY  LUO STROUMBOS         PHONE NO : 978 687 4872   
350 Merrimack St                  SE DECISION MADE: 23-APR-13
LAWRENCE MA 01843                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAYFIELD INFINITY XR2 SKULL CLAMP
INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K130389(TRADITIONAL)
ATTN: JANET  KAY                  PHONE NO : 609 750 2864   
311 ENTERPRISE DR.                SE DECISION MADE: 23-APR-13
PLAINSBORO NJ 08536               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVASIVE NVM5 SYSTEM
NUVASIVE, INC.                    510(k) NO: K123307(TRADITIONAL)
ATTN: SHEILA  BRUSCHI             PHONE NO : 858 320 4515   
7475 LUSK BLVD                    SE DECISION MADE: 23-APR-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACE WITH ISE MODULE (NA+, K+ AND C1- REFERENCE ELECTRODES, CAL A AND CAL B) MODEL 39-10700; ACE GLUCOSE REAGENT MODEL SA
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K123018(TRADITIONAL)
ATTN: HYMAN  KATZ PH.D.           PHONE NO : 973 852 0158   
4 HENDERSON DRIVE                 SE DECISION MADE: 23-APR-13
WEST CALDWELL NJ 07006            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCELEDENT AURA
ORTHOACCEL TECHNOLOGIES, INC      510(k) NO: K130643(SPECIAL)
ATTN: ZAFFER  SYED                PHONE NO : 832 803 0339   
6575 WEST LOOP SOUTH, STE 200     SE DECISION MADE: 23-APR-13
BELLAIRE TX 77401                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
PEGAVISION CORPORATION            510(k) NO: K123973(TRADITIONAL)
ATTN: TONY  HSU                   PHONE NO : 886 332988 08
2F-A NO.5, SHING YEH ST. SHAN DINGSE DECISION MADE: 23-APR-13
TAOYUAN, KWEI SHAN HSIANG    TW 33510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASSEO-35
BIOTRONIK, INC.                   510(k) NO: K130161(TRADITIONAL)
ATTN: JON  BRUMBAUGH              PHONE NO : 888 345 0374   
6024 JEAN ROAD                    SE DECISION MADE: 23-APR-13
LAKE OSWEGO OR 97224              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGISEAL TOPICAL SKIN ADHESIVE
ADHEZION BIOMEDICAL, LLC          510(k) NO: K123936(ABBREVIATED)
ATTN: CARIDAD  SMITH              PHONE NO : 828 572 4201   
ONE MERIDIAN PARKWAY SUITE 1B02   SE DECISION MADE: 24-APR-13
WYOMISSING PA 19610               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
NIPRO DIAGNOSTICS, INC.           510(k) NO: K120989(TRADITIONAL)
ATTN: KAREN  DEVINCENT            PHONE NO : 954 677 9201   
2200 W Cypress Creek Rd           SE DECISION MADE: 24-APR-13
Fort Lauderdale FL 33309          510(k) STATEMENT

DEVICE: PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM
VOLCANO CORPORATION               510(k) NO: K122826(TRADITIONAL)
ATTN: LIDA  QUAGLIA               PHONE NO : 978 439 3586   
1 FORTUNE DRIVE                   SE DECISION MADE: 24-APR-13
BILLERICA MA 01821                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMODULE 3-M1
ZEPHYR TECHNOLOGY CORPORATION     510(k) NO: K123658(TRADITIONAL)
ATTN: RICHARD  KEEN               PHONE NO : 203 329 2700   
1151 HOPE STREET                  SE DECISION MADE: 24-APR-13
STAMFORD CT 06907                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DE48-PLUS
GRASS TECHNOLOGIES, AN ASTRO-MED, 510(k) NO: K123915(TRADITIONAL)
ATTN: PHILLIP  SOARES             PHONE NO : 401 828 4000   
53 AIRPORT PARK DRIVE             SE DECISION MADE: 24-APR-13
ROCKLAND MA 02370                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASCULAR PROBE, VASCULAR PROBE ES
SYNOVIS LIFE TECHNOLOGIES, INC.   510(k) NO: K130896(TRADITIONAL)
ATTN: STEPHANI K AYALA            PHONE NO : 651 796 7300   
2575 UNIVERSITY AVE. W.           SE DECISION MADE: 24-APR-13
ST. PAUL MN 55114                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RHYTHM VIEW
TOPERA, INC.                      510(k) NO: K123295(SPECIAL)
ATTN: MELISSA  WALKER             PHONE NO : 636 405 7498   
1324 CLARKSON CLAYTON CENTER, #332SE DECISION MADE: 24-APR-13
BALLWIN MO 63011                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NVISION VLE IMAGING SYSTEM
NINPOINT MEDICAL, INC.            510(k) NO: K120800(TRADITIONAL)
ATTN: CINDY  DOMECUS, RAC (US & EUPHONE NO : 650 343 4813   
1171 BARROILHET AVE               SE DECISION MADE: 25-APR-13
HILLSBOROUGH CA 94010             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND  RAPIDEASE ORAL FLUID COLLECTOR
BIOPHOR DIAGNOSTICS, INC.         510(k) NO: K122703(TRADITIONAL)
ATTN: NATHANIEL G BUTLIN          PHONE NO : 650 367 4954   
1201 DOUGLAS AVE                  SE DECISION MADE: 25-APR-13
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZAVATION CERVICAL PLATE SYSTEM
ZAVATION LLC                      510(k) NO: K130030(TRADITIONAL)
ATTN: JOHN  WALKER                PHONE NO : 601 919 1119   
501 AVALON WAY                    SE DECISION MADE: 25-APR-13
BRANDON MS 39047                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
BIO-RAD LABORATORIES, INC., CLINIC510(k) NO: K130860(SPECIAL)
ATTN: EBONY  MCKINNIES            PHONE NO : 510 741 6265   
4000 Alfred Nobel Drive           SE DECISION MADE: 25-APR-13
Hercules CA 94547                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
GLOOKO, INC.                      510(k) NO: K130886(SPECIAL)
ATTN: SHILPA  MYDUR               PHONE NO : 650 720 5310   
170A UNIVERSITY AVENUE            SE DECISION MADE: 25-APR-13
PALO ALTO CA 94301                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
CALDERA MEDICAL, INC.             510(k) NO: K123028(TRADITIONAL)
ATTN: VICKI  GAIL                 PHONE NO : 818 879 6555   
5171 CLARETON DRIVE               SE DECISION MADE: 25-APR-13
AGOURA HILLS CA 91301             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VAULT ALIF SYSTEM
SPINAL USA                        510(k) NO: K130445(SPECIAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 25-APR-13
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SERI SURGICAL SCAFFOLD
ALLERGAN                          510(k) NO: K123128(TRADITIONAL)
ATTN: CONNIE  GARRISON            PHONE NO : 781 658 2800   
200 BOSTON AVENUE SUITE 3700      SE DECISION MADE: 25-APR-13
MEDFORD MA 02155 0000             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: METANEB
HILL-ROM SERVICES PTE LTD         510(k) NO: K124032(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155
1 YISHUN AVE 7                    SE DECISION MADE: 25-APR-13
SINGAPORE    SN 768923            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRLIFE
CAREFUSION                        510(k) NO: K123527(TRADITIONAL)
ATTN: ERIKA  FERNANDEZ            PHONE NO : 847 473 7208   
1500 WAUKEGAN ROAD                SE DECISION MADE: 25-APR-13
WAUKEGAN IL 60060                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS
ULTRAPURE & INDUSTRIAL SERVICES LL510(k) NO: K123282(TRADITIONAL)
ATTN: GREG  FRANKS                PHONE NO : 972 432 9951   
4429 MINT WAY                     SE DECISION MADE: 25-APR-13
DALLAS TX 75236                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PANTHEON SPINAL IBFD SYSTEM
PANTHEON SPINAL                   510(k) NO: K113781(TRADITIONAL)
ATTN: SCOTT  SPANN                PHONE NO : 512 415 5151   
9442 CAPITAL OF TEXAS HWY NORTH - SE DECISION MADE: 26-APR-13
AUSTIN TX 78759                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERIOTYPE X-PERT
CLINICAL HOUSE EUROPE GMBH        510(k) NO: K123386(TRADITIONAL)
ATTN: JUDI  WEISSINGER            PHONE NO : 702 294 3133   
9360 WEST FLAMINGO ROAD           SE DECISION MADE: 26-APR-13
LAS VEGAS NV 89147                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BODYTRONIC 200
BAUERFEIND AG                     510(k) NO: K123921(TRADITIONAL)
ATTN: INES  EXNER                 PHONE NO : 49 36628 661350
TRIEBESER STRASSE 16              SE DECISION MADE: 26-APR-13
ZEULENRODA-TRIEBES    GM 07937    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRG BARRIER COAT
SHOFU DENTAL CORPORATION          510(k) NO: K122908(TRADITIONAL)
ATTN: DAVID P MORAIS              PHONE NO : 760 736 3277   
1225 STONE DRIVE                  SE DECISION MADE: 26-APR-13
SAN MARCOS CA 92078               510(k) STATEMENT

DEVICE: CG+ ARROW PICC POWERED BY ARROW VPS STYLET
ARROW INTERNATIONAL, INC.         510(k) NO: K130876(SPECIAL)
ATTN: ELIZABETH  DUNCAN           PHONE NO : 610 378 0131   
2400 BERNVILLE RD.                SE DECISION MADE: 26-APR-13
READING PA 19605                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING
MEDTRONIC VASCULAR                510(k) NO: K123990(TRADITIONAL)
ATTN: KELLEY  LAMKE               PHONE NO : 707 543 5043   
3576 UNOCAL PLACE                 SE DECISION MADE: 26-APR-13
SANTA ROSA CA 95403               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDIT MICROCV VITAMIN D LINEARITY SET
AALTO SCIENTIFIC LTD.             510(k) NO: K130764(TRADITIONAL)
ATTN: DESSI  LYAKOV               PHONE NO : 760 431 6942   
1959 KELLOGG AVE.                 SE DECISION MADE: 26-APR-13
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ICRCO 3600M
ICRCO INC.                        510(k) NO: K122510(TRADITIONAL)
ATTN: GREG  WACHTLER              PHONE NO : 310 921 9559   
2580 WEST 237TH STREET            SE DECISION MADE: 26-APR-13
TORRANCE CA 90505                 510(k) STATEMENT

DEVICE: MULTI ANGLED ABUTMENT
OSSTEM IMPLANT CO., LTD           510(k) NO: K123755(SPECIAL)
ATTN: PATRICK  LIM                PHONE NO : 888 678 0001   
85 BEN FAIRLESS DR.               SE DECISION MADE: 26-APR-13
FAIRLESS HILLS PA 19030           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERILE RADIOLUCENT SKULL PINS
BRAINLAB AG                       510(k) NO: K122225(TRADITIONAL)
ATTN: ALEXANDER  SCHWIERSCH       PHONE NO : 498 999 15680
KAPELLENSTRASSE 12                SE DECISION MADE: 26-APR-13
FELDKIRCHEN    GM 85622           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DENTO TEMP
ITENA CLINICAL                    510(k) NO: K122549(ABBREVIATED)
ATTN: LOUIS-PAUL  MARIN           PHONE NO : 514 928 5546
500 BOUL CARTIER WEST             SE DECISION MADE: 26-APR-13
LAVAL    CA H7V 5B7               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM
OTOTRONIX, LLC                    510(k) NO: K130201(TRADITIONAL)
ATTN: BERNARD  HORWATH            PHONE NO : 651 231 1761   
4486 TIMBERLINE CT                SE DECISION MADE: 26-APR-13
ST PAUL MN 55127                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR
MASIMO CORPORATION                510(k) NO: K120984(TRADITIONAL)
ATTN: PATRICIA  MILBANK           PHONE NO : 949 297 7261   
40 PARKER                         SE DECISION MADE: 26-APR-13
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABBOTT PHENOBARBITAL ASSAY
MICROGENICS CORP.                 510(k) NO: K123271(TRADITIONAL)
ATTN: KAREN  LEE                  PHONE NO : 510 979 5000   
46360 FREMONT BLVD                SE DECISION MADE: 26-APR-13
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REFLOW ASPIRATION CATHETER
VOLCANO CORPORATION               510(k) NO: K123482(TRADITIONAL)
ATTN: BRIAN  PARK                 PHONE NO : 858 720 4176   
3661 VALLEY CENTER DR SUITE 200   SE DECISION MADE: 29-APR-13
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IRIS ANTERIOR CERVICAL PLATE
LIFE SPINE, INC                   510(k) NO: K130202(TRADITIONAL)
ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   
2401 W. HASSELL RD SUITE 1535     SE DECISION MADE: 29-APR-13
HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRAUMANN DENTAL IMPLANT SYSTEM
STRAUMANN USA, LLC                510(k) NO: K130222(TRADITIONAL)
ATTN: JENNIFER M JACKSON, MS      PHONE NO : 978 747 2509   
60 MINUTEMAN ROAD                 SE DECISION MADE: 29-APR-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
PAS SYSTEMS INTERNATIONAL, INC.   510(k) NO: K123470(TRADITIONAL)
ATTN: JAREL R KELSEY              PHONE NO : 540 372 3431   
1616 PRINCESS ANNE STREET         SE DECISION MADE: 29-APR-13
FREDERICKSBURG VA 22401           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET
AALTO SCIENTIFIC LTD.             510(k) NO: K130762(TRADITIONAL)
ATTN: DESSI  LYAKOV               PHONE NO : 760 431 6942   
1959 KELLOGG AVE.                 SE DECISION MADE: 29-APR-13
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMBAT READY CLAMP
COMBAT MEDICAL SYSTEMS, LLC       510(k) NO: K130482(TRADITIONAL)
ATTN: CALLEY  HERZOG              PHONE NO : 720 883 3633   
13417 QUIVAS ST                   SE DECISION MADE: 29-APR-13
WESTMINSTER CO 80234              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SINGLE USE REPOSITIONABLE CLIP
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K123601(TRADITIONAL)
ATTN: SHERI L MUSGNUNG            PHONE NO : 484 896 3147   
3500 CORPORATE PARKWAY            SE DECISION MADE: 29-APR-13
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAGNOSTICPRO EDGE
VIDAR SYSTEMS CORP.               510(k) NO: K130406(TRADITIONAL)
ATTN: CARRIE L BRANCART           PHONE NO : 703 471 7070   
365 Herndon Pkwy                  SE DECISION MADE: 29-APR-13
HERNDON VA 20170                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZUGA DENTAL IMPLANT SYSTEM
ZUGA MEDICAL, INC.                510(k) NO: K122664(TRADITIONAL)
ATTN: KAREN E WARDEN, PHD         PHONE NO : 440 729 8457   
P.O. BOX 566                      SE DECISION MADE: 30-APR-13
CHESTERLAND OH 44026 2141         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NMI PORT
NAVILYST MEDICAL, INC.            510(k) NO: K122767(ABBREVIATED)
ATTN: LORRAINE M HANLEY           PHONE NO : 508 658 7945   
26 FOREST STREET                  SE DECISION MADE: 30-APR-13
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET
SPENCER FILLMORE                  510(k) NO: K123941(TRADITIONAL)
ATTN: CHRISTINA  BERNSTEIN        PHONE NO : 415 450 0515   
2670 LEAVENWORTH ST.              SE DECISION MADE: 30-APR-13
SAN FRANCISCO CA 94133            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM
CDR SYSTEMS, INC.                 510(k) NO: K122888(TRADITIONAL)
ATTN: CARL  DENIS                 PHONE NO : 403 850 7035
#33, 235105 WRANGLER DRIVE S.W.   SE DECISION MADE: 30-APR-13
CALGARY    CA TIX OK3             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER
LUTHER NEEDLESAFE PRODUCTS, INC.  510(k) NO: K130518(TRADITIONAL)
ATTN: REBECCA K PINE              PHONE NO : 760 809 5178   
7 RIMANI DRIVE                    SE DECISION MADE: 30-APR-13
MISSION VIEJO CA 92692            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEPUY M-SPEC 36MM FEMORAL HEADS
DEPUY ORTHOPAEDICS                510(k) NO: K120599(TRADITIONAL)
ATTN: CORRENE  RAMY               PHONE NO : 574 371 4981   
700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 30-APR-13
CORRENE RAMY IN 46582             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126
STERITEC PRODUCTS MFG. CO., INC.  510(k) NO: K122945(ABBREVIATED)
ATTN: JONATHAN  RUTIGLIANO        PHONE NO : 303 660 4201   
74 INVERNESS DRIVE EAST           SE DECISION MADE: 30-APR-13
ENGLEWOOD CO 80112                510(k) STATEMENT

DEVICE: WVSM (WIRLESS VITAL SIGNS MONITOR)
ATHENA GTX                        510(k) NO: K130957(SPECIAL)
ATTN: SEAN  MAHONEY               PHONE NO : 515 288 3360   
3620 SW61ST STREET SUITE 395      SE DECISION MADE: 30-APR-13
DES MOINES IA 50321               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROSTAR TMS THERAPY SYSTEM
NEURONETICS                       510(k) NO: K130233(TRADITIONAL)
ATTN: JUDY P WAYS, PH.D.          PHONE NO : 610 640 4202   
31 GENERAL WARREN BLVD            SE DECISION MADE: 30-APR-13
MALVERN PA 19355 1245             510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   248                                     
                                                 TOTAL WITH SUMMARIES        228                                     
                                                 TOTAL WITH STATEMENTS        20