Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Medical Devices

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
                                      

Page Last Updated: 01/13/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.