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510(k)s Final Decisions Rendered for June 2005 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-JUN-2005 THROUGH 30-JUN-2005 DEVICE: IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677 ABBOTT LABORATORIES 510(k) NO: K051125(SPECIAL)
ATTN: KIM SMITH-SERVANCE PHONE NO : 650-474-3383 400 SAGINAW DRIVE SE DECISION MADE: 08-JUN-05 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12X ABBOTT LABORATORIES (PERCLOSE, INC510(k) NO: K051519(SPECIAL)
ATTN: ANN E LEONARD PHONE NO : 650-474-3477 400 SAGINAW DRIVE SE DECISION MADE: 21-JUN-05 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ON CALL MULTI-DRUG HOME TEST CUP ACON LABORATORIES, INC. 510(k) NO: K050878(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030 4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 08-JUN-05 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST ACON LABORATORIES, INC. 510(k) NO: K050936(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030 4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 24-JUN-05 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES ACTA VASCULAR SYSTEMS, INC. 510(k) NO: K042297(ABBREVIATED)
ATTN: RICHARD M RUEDY PHONE NO : 408-828-7281 247 MARCHMONT DR. SE DECISION MADE: 01-JUN-05 LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECEDENCE SPECT/CT IMAGING SYSTEM ADAC LABORATORIES 510(k) NO: K051351(TRADITIONAL)
ATTN: COLEEN A COLEMAN PHONE NO : 408-468-3051 540 ALDER DR. SE DECISION MADE: 08-JUN-05 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TA ADVANCED SPINAL TECHNOLOGIES, INC.510(k) NO: K050428(TRADITIONAL)
ATTN: JEFFREY R PERELMAN PHONE NO : 561-886-3224 433 PLAZA REAL, SUITE 255 SE DECISION MADE: 14-JUN-05 BOCA RATON, FL 33432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESKULISA TTG A AND AESKULISA TTG G AESKU, INC 510(k) NO: K042644(TRADITIONAL)
ATTN: STANLEY AMMONS PHONE NO : 703-860-5057 8880 NORTHWEST 18TH TERRACE SE DECISION MADE: 01-JUN-05 MIAMI, FL 33172 510(k) STATEMENT DEVICE: VISULIZE FACTOR IX ANTIGEN KIT AFFINITY BIOLOGICALS INC. 510(k) NO: K051054(TRADITIONAL)
ATTN: DENISE FOULON PHONE NO : 905 304 9896 1395 SANDHILL DRIVE SE DECISION MADE: 29-JUN-05 ANCASTER, CANADA L9G 4V5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE AIR SAFETY LTD 510(k) NO: K050953(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 29-JUN-05 MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED ULTRASONIC SCALPELS ALLIANCE MEDICAL CORP. 510(k) NO: K043358(TRADITIONAL)
ATTN: ELIZABETH RENKEN PHONE NO : 480-763-5394 10232 SOUTH 51ST ST. SE DECISION MADE: 06-JUN-05 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVIC ALLIANCE MEDICAL CORP. 510(k) NO: K051554(SPECIAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5300 10232 SOUTH 51ST ST. SE DECISION MADE: 29-JUN-05 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVOLIX AND REVOLIX JR ALLMED SYSTEMS INC. 510(k) NO: K051167(TRADITIONAL)
ATTN: PETER N ALLEN PHONE NO : 925-468-0433 9232 KLEMETSON DRIVE SE DECISION MADE: 01-JUN-05 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZODIAC SPINAL FIXATION SYSTEM ALPHATEC/NEXMED 510(k) NO: K050830(TRADITIONAL)
ATTN: ELLEN A YARNALL PHONE NO : 760-431-9286 6110 CORTE DEL CEDRO SE DECISION MADE: 22-JUN-05 CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZODIAC SPINAL FIXATION SYSTEM ALPHATEC/NEXMED 510(k) NO: K051286(SPECIAL)
ATTN: ELLEN A YARNALL PHONE NO : 760-431-9286 6110 CORTE DEL CEDRO SE DECISION MADE: 17-JUN-05 CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMS COLLAGEN DERMAL MATRIX AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K050445(TRADITIONAL)
ATTN: ELSA LINKE PHONE NO : 952-930-6309 10700 BREN RD., WEST SE DECISION MADE: 17-JUN-05 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSURE 100% SILICONE FOLEY CATHETER AMSINO INTERNATIONAL, INC. 510(k) NO: K051059(TRADITIONAL)
ATTN: CHING CHING SEAH PHONE NO : 909-626-5888 855 TOWNE CENTER DR. SE DECISION MADE: 28-JUN-05 POMONA, CA 91767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320 ANALOGIC CORP. 510(k) NO: K050919(ABBREVIATED)
ATTN: DONALD SHERRATT PHONE NO : 978-326-4075 8 CENTENNIAL DR. SE DECISION MADE: 14-JUN-05 CENTENNIAL INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA PEABODY, MA 01960 DEVICE: FISHVIEW APPLIED SPECTRAL IMAGING, LTD. 510(k) NO: K050236(TRADITIONAL)
ATTN: DAN LAOR PHONE NO : 972 4 8246632 6 SIRENI ST. SE DECISION MADE: 27-JUN-05 HAIFA, ISRAEL 32972 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM ARC SURGICAL LLC. 510(k) NO: K043176(TRADITIONAL)
ATTN: ED BOEHMER PHONE NO : 503-645-9300 5885 NW CORNELIUS PASS ROAD SE DECISION MADE: 17-JUN-05 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA HILLSBORO, OR 97124 DEVICE: ARI COLD SPRAY ARI 510(k) NO: K033720(TRADITIONAL)
ATTN: RON ARKIN PHONE NO : 770-565-6166 1733 CANTON LN. SE DECISION MADE: 10-JUN-05 MARIETTA, GA 30062-2679 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPOTCHEM II LDH AND GGT TESTS ARKRAY, INC. 510(k) NO: K050790(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 206-262-7363 510 FURNACE DOCK RD. SE DECISION MADE: 06-JUN-05 CORTLANDT MANOR, NY 10567 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS ARKRAY, INC. 510(k) NO: K051432(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 206-262-7363 510 FURNACE DOCK RD. SE DECISION MADE: 17-JUN-05 CORTLANDT MANOR, NY 10567 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PUSHLOCK ARTHREX, INC. 510(k) NO: K051219(SPECIAL)
ATTN: SALLY FOUST PHONE NO : 239-643-5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 29-JUN-05 NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARALLAX ACRYLIC RESIN WITH TRACERS TA ARTHROCARE CORP. 510(k) NO: K050864(TRADITIONAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-735-6426 680 VAQUEROS AVE. SE DECISION MADE: 17-JUN-05 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER ARTHROTEK, INC. 510(k) NO: K051069(TRADITIONAL)
ATTN: GARY BAKER PHONE NO : 574-267-6639 P.O. BOX 587 SE DECISION MADE: 29-JUN-05 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REXEED SERIES DIALYZERS ASAHI KASEI MEDICAL CO., LTD. 510(k) NO: K051187(SPECIAL)
ATTN: DAVID L WEST PHONE NO : 301-272-3113 1801 ROCKVILLE PIKE, SUITE 300 SE DECISION MADE: 08-JUN-05 ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRICURE ISOLATOR TRANSPOLAR PEN ATRICURE, INC. 510(k) NO: K050459(TRADITIONAL)
ATTN: ELSA ABRUZZO PHONE NO : 513-755-4105 6033 SCHUMACHER PARK DR. SE DECISION MADE: 13-JUN-05 WEST CHESTER, OH 45069 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR AXYA MEDICAL, INC. 510(k) NO: K051250(SPECIAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510 100 CUMMINGS CENTER SE DECISION MADE: 09-JUN-05 SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA BEVERLY, MA 01915 DEVICE: BTI-SCAN, VERSION 4.0 B.T.I. BIOTECHNOLOGY INSTITUTE, S.510(k) NO: K051392(TRADITIONAL)
ATTN: LEYRE ZUNIGA HERNANDO PHONE NO : 34 945 297030 LEONARDO DA VINCI, 14 B SE DECISION MADE: 29-JUN-05 MINANO MENOR, ALAVA, SPAIN 01510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARRX HALO 360 SYSTEM, MODEL 1100C-115A BARRX MEDICAL, INCORPORATED 510(k) NO: K051168(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 29-JUN-05 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA IMS LITHIUM ASSAY BAYER HEALTHCARE, LLC 510(k) NO: K050374(TRADITIONAL)
ATTN: ANDRES HOLLE PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 15-JUN-05 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BN BAYER HEALTHCARE, LLC 510(k) NO: K051265(TRADITIONAL)
ATTN: ANDRES HOLLE PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 13-JUN-05 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT BECKMAN COULTER, INC. 510(k) NO: K051307(SPECIAL)
ATTN: ANNETTE HELLIE PHONE NO : 714-993-8767 200 SOUTH KRAEMER BLVD. W-110 SE DECISION MADE: 13-JUN-05 BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) BECTON, DICKINSON & CO. 510(k) NO: K051109(TRADITIONAL)
ATTN: MINICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 15-JUN-05 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0 BECTON, DICKINSON & CO. 510(k) NO: K051138(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 03-JUN-05 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) BECTON, DICKINSON & CO. 510(k) NO: K051183(TRADITIONAL) ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 21-JUN-05 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625 BECTON, DICKINSON & CO. 510(k) NO: K051204(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 24-JUN-05 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIODERM SCIENCES WOUND HEALING SPRAY BIODERM SCIENCES, INC. 510(k) NO: K042084(TRADITIONAL)
ATTN: EDWARD R GUBISH PHONE NO : 301-216-3912 101 ORCHARD RIDGE DR. SE DECISION MADE: 15-JUN-05 SUITE 1N 510(k) SUMMARY AVAILABLE FROM FDA GAITHERSBURG, MD 20878 DEVICE: COOL.CLICK BIOJECT, INC. 510(k) NO: K050734(TRADITIONAL)
ATTN: MELANIE TALBERT PHONE NO : 800-683-7221 20245 S.W. 95TH AVE. SE DECISION MADE: 03-JUN-05 TUALATIN, OR 97062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAPER 2 POROUS FEMORAL STEM BIOMET, INC. 510(k) NO: K050441(TRADITIONAL)
ATTN: KACY ARNOLD PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 29-JUN-05 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS BIOMET, INC. 510(k) NO: K051411(SPECIAL)
ATTN: TRACY BICKEL JOHNSON PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 29-JUN-05 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46582 DEVICE: CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & BIOSENSE WEBSTER, INC. 510(k) NO: K050877(SPECIAL)
ATTN: MICHAEL JOHNSON PHONE NO : 909-839-8468 3333 DIAMOND CANYON RD. SE DECISION MADE: 24-JUN-05 DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D BIOSITE INCORPORATED 510(k) NO: K050799(TRADITIONAL)
ATTN: RACHAEL S WILLIAMSON PHONE NO : 858-455-4808 11030 ROSELLE ST. SE DECISION MADE: 29-JUN-05 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMOTE CARE MANAGEMENT SYSTEMS (RCMS) BL HEALTHCARE, INC. 510(k) NO: K051470(TRADITIONAL)
ATTN: MICHAEL MATHUR PHONE NO : 508-543-4150 33 COMMERCIAL ST., SUITE #3 SE DECISION MADE: 08-JUN-05 FOXBORO, MA 02035 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM BLACKSTONE MEDICAL, INC. 510(k) NO: K043548(TRADITIONAL)
ATTN: DEAN E CIPORKIN PHONE NO : 413-726-2513 90 BROOKSDALE DR. SE DECISION MADE: 14-JUN-05 SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSTRUX MINI PEEK VBR SYSTEM BLACKSTONE MEDICAL, INC. 510(k) NO: K051246(TRADITIONAL)
ATTN: DEAN E CIPORKIN PHONE NO : 413-726-2513 90 BROOKSDALE DR. SE DECISION MADE: 14-JUN-05 SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 30 ML OR 60 ML PEDI-SYRINGE FILTER BLOOD PRODUCTS SPECIALTIES LLC 510(k) NO: K050805(TRADITIONAL)
ATTN: ALAN A WALDMAN PHONE NO : 516-763-1158 184 SEIFFERT COURT SE DECISION MADE: 20-JUN-05 OCEANSIDE, NY 11572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PV 1900 SYNCHRO 0.016 GUIDEWIRE BOSTON SCIENTIFIC - PRECISION VASC510(k) NO: K050964(SPECIAL)
ATTN: RICK GAYKOWSKI PHONE NO : 801-974-1700 2405 WEST ORTON CIR. SE DECISION MADE: 13-JUN-05 WEST VALLEY CITY, UT 84119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K050599(SPECIAL)
ATTN: VICTOR HAM PHONE NO : 510-440-7604 47900 BAYSIDE PARKWAY SE DECISION MADE: 03-JUN-05 FREMONT, CA 94538-6515 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 BOSTON SCIENTIFIC CORP. 510(k) NO: K051179(SPECIAL)
ATTN: CATHERINE A PETERS PHONE NO : 650-623-1755 2011 STIERLIN CT. SE DECISION MADE: 08-JUN-05 MOUNTAIN VIEW, CA 94043-4655 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASY CORE DETACHABLE BIOPSY SYSTEM BOSTON SCIENTIFIC CORP. 510(k) NO: K051361(SPECIAL)
ATTN: CHRISTINE M CAMERON PHONE NO : 508-683-4471 100 FAIRBANKS BOULEVARD SE DECISION MADE: 16-JUN-05 MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPYSCOPE ACCESS AND DELIVERY CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K051504(TRADITIONAL)
ATTN: JENNIFER JOHNSON PHONE NO : 508-683-4178 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 16-JUN-05 MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PERIPHERAL CUTTING BALLOON BOSTON SCIENTIFIC IVT 510(k) NO: K051254(TRADITIONAL)
ATTN: RENUKA KRISHNAN PHONE NO : 858-503-1815 3574 RUFFIN RD. SE DECISION MADE: 22-JUN-05 SAN DIEGO, CA 92123-3597 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 6 FR DL POWERPICC CATHETER C.R. BARD, INC. 510(k) NO: K050931(SPECIAL)
ATTN: PEGGY KEIFFER PHONE NO : 801-595-0700 5425 WEST AMELIA EARHART DR. SE DECISION MADE: 15-JUN-05 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 6 FR FL POWERHOHN AND POWERLINE CATHETER C.R. BARD, INC. 510(k) NO: K051417(SPECIAL)
ATTN: PEGGY KEIFFER PHONE NO : 801-595-0700 5425 WEST AMELIA EARHART DR. SE DECISION MADE: 30-JUN-05 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA FAMILY OF PULSE DYE LASER SYSTEMS CANDELA CORP. 510(k) NO: K050673(TRADITIONAL)
ATTN: LORRAINE CALZETTA PATROVIC PHONE NO : 508-358-7637 530 BOSTON POST RD. SE DECISION MADE: 13-JUN-05 WAYLAND, MA 01886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG CARDIODYNAMICS INTERNATIONAL CORP.510(k) NO: K051228(TRADITIONAL)
ATTN: DENNIS HEPP PHONE NO : 858-535-0202 6175 NANCY RIDGE DR., #300 SE DECISION MADE: 10-JUN-05 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE CARDIOPULMONARY CORP. 510(k) NO: K051283(SPECIAL)
ATTN: JORDAN SCHRECK PHONE NO : 203-301-6227 200 CASCADE BLVD. SE DECISION MADE: 23-JUN-05 MILFORD, CT 06460 510(k) STATEMENT DEVICE: 750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM CAS MEDICAL SYSTEMS, INC. 510(k) NO: K050844(TRADITIONAL)
ATTN: RON JEFFREY PHONE NO : 203-488-6056 44 EAST INDUSTRIAL RD. SE DECISION MADE: 23-JUN-05 BRANFORD, CT 06405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAVEX ORTHOTRACE CAVEX HOLLAND B.V. 510(k) NO: K051207(TRADITIONAL)
ATTN: RICHARD WOORTMAN PHONE NO : 31 23 5307763 HARMENJANSWEG 19 SE DECISION MADE: 21-JUN-05 P.O. BOX 852 510(k) STATEMENT HAARLEM, NETHERLANDS 2003 RW DEVICE: CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CER CEREMED, INC. 510(k) NO: K051293(TRADITIONAL)
ATTN: TADEUSZ WELLISZ PHONE NO : 310-815-2125 3643 LENAWEE AVE. SE DECISION MADE: 14-JUN-05 LOS ANGELES, CA 90016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A CHONGQING XINFENG MEDICAL INSTRUME510(k) NO: K043558(TRADITIONAL)
ATTN: GEORGE SU PHONE NO : 310-229-5748 1800 CENTURY PARK E, STE 600 SE DECISION MADE: 06-JUN-05 CENTURY CITY, CA 90067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED TROCARS CLEAR MEDICAL, INC. 510(k) NO: K033591(TRADITIONAL)
ATTN: MIKE KOVACS PHONE NO : 425-401-1414 1776 136TH PL. NE SE DECISION MADE: 03-JUN-05 BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOTINE RIBBON COAPT SYSTEMS, INC. 510(k) NO: K051415(TRADITIONAL)
ATTN: LINDA RUEDY PHONE NO : 650-461-7647 1820 EMBARCADERO RD. SE DECISION MADE: 23-JUN-05 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JET BLUE BITE COLTENE/WHALEDENT AG 510(k) NO: K051243(TRADITIONAL)
ATTN: HENRY J VOGELSTEIN PHONE NO : 212-289-4748 1349 LEXINGTON AVENUE SE DECISION MADE: 23-JUN-05 NEW YORK, NY 10128 510(k) STATEMENT DEVICE: CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20- CONFLUENT SURGICAL,INC 510(k) NO: K050998(TRADITIONAL)
ATTN: ERIC P ANKERUD PHONE NO : 781-693-2333 101A FIRST AVE. SE DECISION MADE: 15-JUN-05 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING COVALON TECHNOLOGIES, INC. 510(k) NO: K043296(TRADITIONAL)
ATTN: PAUL L GUILBAUD PHONE NO : 727-595-8184 14510 KANDI COURT SE DECISION MADE: 06-JUN-05 LARGO, FL 33774 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYNERGY MULTIPLEX LASER CYNOSURE, INC. 510(k) NO: K050779(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 27-JUN-05 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DADE THROMBIN REAGENT DADE BEHRING, INC. 510(k) NO: K050928(TRADITIONAL)
ATTN: KATHELEEN A DRAY-LYONS PHONE NO : 781-826-4551 GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 29-JUN-05 BLDG. 500 M.S. 514 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DRIED GRAM-POSITIVE MIC/COMBO PANELS DADE BEHRING, INC. 510(k) NO: K051202(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 2040 ENTERPRISE BLVD. SE DECISION MADE: 23-JUN-05 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C.CAM-AC DANISH DIAGNOSTIC DEVELOPMENT A/S 510(k) NO: K051460(TRADITIONAL)
ATTN: NIELS SORENSEN PHONE NO : 454 576 8888 DR. NEERGAARDSVEJ 5F SE DECISION MADE: 15-JUN-05 HORSHOLM, DENMARK 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DATEX-OHMEDA OXY-AFR SENSOR DATEX-OHMEDA 510(k) NO: K042891(TRADITIONAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685 86 PILGRIM RD. SE DECISION MADE: 29-JUN-05 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE DATEX-OHMEDA CENTIVA/5 VENTILATOR DATEX-OHMEDA, INC. 510(k) NO: K050860(TRADITIONAL)
ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551 PO BOX 7550 SE DECISION MADE: 21-JUN-05 MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRIADENT ESTHETICAP DENTSPLY INTERNATIONAL 510(k) NO: K050208(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 W. PHILADELPHIA ST. SE DECISION MADE: 14-JUN-05 SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: MODIFICATION TO: CERCON BASE DENTSPLY INTL. 510(k) NO: K051462(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 WEST PHILADELPHIA STREET SE DECISION MADE: 24-JUN-05 SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DENVER BIOMEDICALS, INC. 510(k) NO: K051084(SPECIAL)
ATTN: NANCY SAUER PHONE NO : 303-526-7402 433 PARK POINT DRIVE, SUITE 14 SE DECISION MADE: 13-JUN-05 GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIADEXUS PLAC TEST DIADEXUS, INC. 510(k) NO: K050523(TRADITIONAL)
ATTN: JULIE BLACKLOCK PHONE NO : 650-246-6477 343 OYSTER POINT BLVD. SE DECISION MADE: 15-JUN-05 SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIASORIN LIAISON CMV IGM/IGG DIASORIN S.P.A. 510(k) NO: K040290(TRADITIONAL)
ATTN: DAVID M IKEDA PHONE NO : 651-351-5592 1951 NORTHWESTERN AVE. SE DECISION MADE: 01-JUN-05 P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA STILLWATER, MN 55082-0285 DEVICE: KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 EASTMAN KODAK COMPANY 510(k) NO: K051258(SPECIAL)
ATTN: CHRISTINE E EHMANN PHONE NO : 585-724-4487 343 STATE STREET SE DECISION MADE: 01-JUN-05 ROCHESTER, NY 14650 510(k) STATEMENT DEVICE: KODAK DIRECTVIEW DR SYSTEM DETECTOR EASTMAN KODAK COMPANY 510(k) NO: K051483(TRADITIONAL)
ATTN: CHRISTINE E EHMANN PHONE NO : 585-724-4487 343 STATE ST. SE DECISION MADE: 21-JUN-05 ROCHESTER, NY 14650-1131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EKOS MICRO-INFUSION SYSTEM EKOS CORP. 510(k) NO: K051225(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1108 22030 20TH AVENUE S.E. SE DECISION MADE: 10-JUN-05 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98021 DEVICE: MODIFICATION TO: LYSUS INFUSION SYSTEM EKOS CORP. 510(k) NO: K051319(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1108 22030 20TH AVENUE S.E. SE DECISION MADE: 15-JUN-05 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98021 DEVICE: GAMMAPLAN ELEKTA INSTRUMENT AB 510(k) NO: K051022(TRADITIONAL)
ATTN: PETER LOWENDAHL PHONE NO : 011 46 858725400 KUNGSTENSGATAN 18 SE DECISION MADE: 01-JUN-05 PO BOX 7593 510(k) SUMMARY AVAILABLE FROM FDA STOCKHOLM, SWEDEN SE-103 93 DEVICE: MYLAB 70 ULTRASOUND IMAGING SYSTEM ESAOTE, S.P.A. 510(k) NO: K051308(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-849-1916 7992 CASTLEWAY DRIVE SE DECISION MADE: 01-JUN-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, ETHICON ENDO-SURGERY, INC. 510(k) NO: K051036(TRADITIONAL)
ATTN: RACHEL D AUSTIN PHONE NO : 513-337-3419 4545 CREEK RD. SE DECISION MADE: 02-JUN-05 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONOCRYL PLUS ANTIBACTERIAL SUTURE ETHICON, INC. 510(k) NO: K050845(TRADITIONAL)
ATTN: JENNIFER M PAINE PHONE NO : 908-218-3323 ROUTE 22 WEST SE DECISION MADE: 29-JUN-05 P.O.BOX 151 510(k) SUMMARY AVAILABLE FROM FDA SOMERVILLE, NJ 08876 DEVICE: PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT EV3 CORPORATION 510(k) NO: K051379(SPECIAL)
ATTN: GLEN D SMYTHE PHONE NO : 763-398-7391 4600 NATHAN LN. NORTH SE DECISION MADE: 17-JUN-05 PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS EXACTECH, INC. 510(k) NO: K051335(SPECIAL)
ATTN: MARITZA ELIAS PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 21-JUN-05 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FACEMASTER FACIAL TONING SYSTEM FACEMASTER OF BEVERLY HILLS, INC. 510(k) NO: K040871(TRADITIONAL)
ATTN: C. STEPHEN LAWRENCE PHONE NO : 949-440-0400 THREE PARK PLAZA, SUITE 1570 SE DECISION MADE: 01-JUN-05 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMEDIA PROTHROMBIN TIME SYSTEM FARALLON MEDIAL INC 510(k) NO: K050243(TRADITIONAL)
ATTN: JAMES MCKINLEY PHONE NO : 510-785-0800 3521 INVESTEMENT BLVD SE DECISION MADE: 06-JUN-05 SUITE 1 510(k) SUMMARY AVAILABLE FROM FDA HAYWARD, CA 94545 DEVICE: FT FIBER OPTIC DELIVERY SYSTEMS FIBERTECH GMBH 510(k) NO: K050738(TRADITIONAL)
ATTN: ARMIN KAUS PHONE NO : 480-892-4528 4111 E. VALLEY AUTO DRIVE SE DECISION MADE: 02-JUN-05 SUITE 104 510(k) SUMMARY AVAILABLE FROM FDA MESA, AZ 85206 DEVICE: ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 FIM MEDICAL 510(k) NO: K050424(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 947-374-1727 PO BOX 7007 SE DECISION MADE: 23-JUN-05 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS ART HEMOADSORPTION SYSTEM FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K050273(TRADITIONAL)
ATTN: JANET KAY PHONE NO : 781-402-9068 95 HAYDEN AVE. SE DECISION MADE: 08-JUN-05 LEXINGTON, MA 02420-9192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE VIVID 7 WITH OR WITHOUT SUFFIX GE MEDICAL SYSTEMS 510(k) NO: K051449(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 16-JUN-05 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 250 SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K050583(SPECIAL)
ATTN: MELISSA ROBINSON PHONE NO : 813-887-2133 4502 WOODLAND CORPORATE BLVD. SE DECISION MADE: 21-JUN-05 TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000 GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K051367(SPECIAL)
ATTN: TYLER SEDONE PHONE NO : 813-887-2133 4502 WOODLAND CORPORATE BLVD. SE DECISION MADE: 20-JUN-05 TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HBA1C ENZYMATIC ASSAY GENERAL ATOMICS 510(k) NO: K050178(TRADITIONAL)
ATTN: HUAN TRAN PHONE NO : 858-455-4761 3550 GENERAL ATOMICS COURT SE DECISION MADE: 28-JUN-05 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIODAY GETEMED MEDIZIN- UND INFORMATIONST510(k) NO: K051471(TRADITIONAL)
ATTN: BERT SCHADOW PHONE NO : +49 332 839420 55 NORTHERN BLVD SE DECISION MADE: 29-JUN-05 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 THIRD PARTY REVIEW DEVICE: COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE GLOVCO (M) SDN. BHD. 510(k) NO: K051345(TRADITIONAL)
ATTN: TAN PENG HOCK PHONE NO : 603 329 13888 LOT 760 JALAN HAJI SIRAT SE DECISION MADE: 23-JUN-05 KLANG 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 42100 DEVICE: POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH PLASTICIZER GLOVECO, INC. 510(k) NO: K051166(TRADITIONAL)
ATTN: MICKY LIN PHONE NO : 909-591-7888 3973 SCHAEFER AVENUE SE DECISION MADE: 07-JUN-05 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBR GOOD BIOTECH CORP. 510(k) NO: K050713(TRADITIONAL)
ATTN: VICTOR CHIOU PHONE NO : 886 423 596873 38, 34TH RD. SE DECISION MADE: 06-JUN-05 TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA TAICHUNG CITY, CHINA (TAIWAN) 407 DEVICE: ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM GVI TECHNOLOGY PARTNERS 510(k) NO: K051402(SPECIAL)
ATTN: KEVIN M MURROCK PHONE NO : 330-963-4083 1470 ENTERPRISE PKWY. SE DECISION MADE: 13-JUN-05 TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENHANCE CLITORAL STIMULATION AID GYNAVATIONS, INC. 510(k) NO: K043480(TRADITIONAL)
ATTN: DAVID GLOTH PHONE NO : 781-322-4575 665 SALEM STREET SE DECISION MADE: 08-JUN-05 MALDEN, MA 02148 510(k) STATEMENT DEVICE: HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY HAAG-STREIT USA, INC. 510(k) NO: K051103(TRADITIONAL)
ATTN: EDUARDO MARCH PHONE NO : 301-838-3120 7361 CALHOUN PLACE, SUITE 500 SE DECISION MADE: 07-JUN-05 ROCKVILLE, MD 20855-2765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW) HARTALEGA SDN BHD 510(k) NO: K050277(TRADITIONAL)
ATTN: NURUL AISYAH KONG PHONE NO : 603 327 10178 LOT 9, JALAN KUANG BULAN,TAMAN SE DECISION MADE: 07-JUN-05 KEPONG IND. ESTATE 510(k) SUMMARY AVAILABLE FROM FDA SELANGOR, DARUL EHSAN, MALAYSIA 52100 DEVICE: BPCALIBRATOR MC3000/MC3100 HEALTHSTATS INTERNATIONAL PTE. LTD510(k) NO: K051546(TRADITIONAL)
ATTN: STEPHEN GORSKI PHONE NO : 262-594-2114 565 W35739 PIPER ROAD SE DECISION MADE: 24-JUN-05 EAGLE, WI 53119 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: WEBPAX, MODEL 200 HEART IMAGING TECHNOLOGIES, LLC 510(k) NO: K051325(TRADITIONAL)
ATTN: ROBERT M JUDD PHONE NO : 919-384-5044 108 BARTON LANE SE DECISION MADE: 15-JUN-05 CHAPEL HILL, NC 27516 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM HEARTLAB, INC. 510(k) NO: K050858(ABBREVIATED)
ATTN: RICHARD PETROCELLI PHONE NO : 401-596-0592 1 CROSSWIND RD. SE DECISION MADE: 29-JUN-05 WESTERLY, RI 02891 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) HEBEI MANFUL IMPORT & EXPORT CO., 510(k) NO: K051154(TRADITIONAL)
ATTN: YANCHAI ZHANG PHONE NO : 86 311 4338239 NO. 58 TONGDA ROAD SE DECISION MADE: 20-JUN-05 JINZHOU CITY, HEBEI, CHINA 052260 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMCON BANDAGE AND HEMCON BANDAGE OTC HEMCON, INC. 510(k) NO: K043050(ABBREVIATED)
ATTN: JOHN W MORGAN PHONE NO : 503-245-0459 10575 SW CASCADE BLVD. SE DECISION MADE: 03-JUN-05 SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA TIGARD, OR 97223 DEVICE: IBOND NEXT GENERATION HERAEUS KULZER GMBH 510(k) NO: K051006(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662 4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 07-JUN-05 SOUTH BEND, IN 46614-2517 510(k) STATEMENT DEVICE: ABX ERYTROL HORIBA ABX 510(k) NO: K050721(TRADITIONAL)
ATTN: TIM LAWTON PHONE NO : 334 671 47320 PARC EUROMEDECINE SE DECISION MADE: 01-JUN-05 RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA MONTPELLIER, FRANCE 34184 DEVICE: RESTORATION MODULAR SYSTEM HOWMEDICA OSTEONICS CORP 510(k) NO: K051363(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718 325 CORPORATE DR. SE DECISION MADE: 23-JUN-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOFFMANN II MRI EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K051306(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 325 CORPORATE DRIVE SE DECISION MADE: 17-JUN-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLITE C1 Q-SWITCHED ND:YAG LASER HOYA PHOTONICS, INC. 510(k) NO: K050696(TRADITIONAL)
ATTN: JIM GREEN PHONE NO : 800-532-1064 47733 FREMONT BLVD. SE DECISION MADE: 17-JUN-05 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTE510(k) NO: K050852(TRADITIONAL)
ATTN: ALBERT LIPPINCOTT PHONE NO : 952-492-5858 3150 E. 200TH ST. SE DECISION MADE: 22-JUN-05 PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREVAIL DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. 510(k) NO: K051189(TRADITIONAL)
ATTN: JIM BANIC PHONE NO : 561-776-6932 4555 RIVERSIDE DR. SE DECISION MADE: 08-JUN-05 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 IMPLEX CORP. 510(k) NO: K051196(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800 80 COMMERCE DRIVE SE DECISION MADE: 17-JUN-05 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA LITE SP100 ELISA INOVA DIAGNOSTICS, INC. 510(k) NO: K050662(TRADITIONAL)
ATTN: GARY L NORMAN PHONE NO : 858-586-9900 10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 13-JUN-05 SAN DIEGO, CA 92131 510(k) STATEMENT DEVICE: SUPER VIEW DISPOSABLE BIOM LENS SET INSIGHT INSTRUMENTS, INC. 510(k) NO: K051630(TRADITIONAL)
ATTN: MICHAEL ANNEN PHONE NO : 407-324-0388 5400 SOUTH BRYANT AVE. SE DECISION MADE: 29-JUN-05 SANFORD, FL 32773 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS INTELIFUSE, INC. 510(k) NO: K051408(TRADITIONAL)
ATTN: SHARON ROCKWELL PHONE NO : 714-695-9269 5582 CHALON ROAD SE DECISION MADE: 29-JUN-05 YORBA LINDA, CA 92886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMC DRAPES INTL. MEDSURG CONNECTION, INC. 510(k) NO: K050538(TRADITIONAL)
ATTN: MANNY GUPTA PHONE NO : 847-619-9929 935 N. PLUM GROVE RD. STE. F SE DECISION MADE: 07-JUN-05 SCHAUMBURG, IL 60173-4770 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORO INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K050915(SPECIAL)
ATTN: PAMELA MISAJON PHONE NO : 760-918-1820 6354 CORTE DEL ABETO SE DECISION MADE: 07-JUN-05 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA CARLSBAD, CA 92009 DEVICE: SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERI INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K050916(SPECIAL)
ATTN: PAMELA MISAJON PHONE NO : 760-918-1820 6354 CORTE DEL ABETO SE DECISION MADE: 08-JUN-05 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA CARLSBAD, CA 92009 DEVICE: IMAGEQUBE PACS INTUITIVE IMAGING INFORMATICS, LLC510(k) NO: K051037(TRADITIONAL)
ATTN: DONALD MUNDT PHONE NO : 818-347-8919 30 HACKAMORE LN., SUITE 4 SE DECISION MADE: 28-JUN-05 BELL CANYON, CA 91307 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND INTUITIVE SURGICAL, INC. 510(k) NO: K050802(TRADITIONAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100 950 KIFER RD. SE DECISION MADE: 29-JUN-05 SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAC-127-8 CARDOAC ARRAY COIL INVIVO CORP. 510(k) NO: K051512(TRADITIONAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 N27 W23676 PAUL ROAD SE DECISION MADE: 28-JUN-05 PEWAUKEE, WI 53072 510(k) STATEMENT DEVICE: WHS-1000 WOUND HEALING SYSTEM IYIA TECHNOLOGIES, INC. 510(k) NO: K050156(TRADITIONAL)
ATTN: ALAN DONALD PHONE NO : 858-485-8584 11440 WEST BERNARDO COURT SE DECISION MADE: 17-JUN-05 SUITE 380 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92127 DEVICE: JAN MAO WHEELCHAIR, MODEL JMC611-F18EPP JAN MAO INDUSTRIES CO., LTD. 510(k) NO: K051481(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58 FU-CHIUN ST. SE DECISION MADE: 29-JUN-05 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JAN MAO WHEELCHAIR, MODEL JMC612-F18EPP JAN MAO INDUSTRIES CO., LTD. 510(k) NO: K051482(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58 FU-CHIUN ST. SE DECISION MADE: 29-JUN-05 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0 KIKA MEDICAL INC. 510(k) NO: K051127(TRADITIONAL)
ATTN: HOWARD HOSTEIN PHONE NO : 202-637-637 555 THIRTEENTH STREET, NW. SE DECISION MADE: 03-JUN-05 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE KIMBERLY-CLARK CORP. 510(k) NO: K051347(SPECIAL)
ATTN: RICHARD V WOLFE PHONE NO : 770-587-8208 1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 07-JUN-05 ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K051521(TRADITIONAL)
ATTN: SHINICHI YAMANAKA PHONE NO : 815 963 70190 319 AKENO OBATA-CHO SE DECISION MADE: 28-JUN-05 WATARAI-GUN, MIE-KEN, JAPAN 519-05510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KOO AMERICAS VALVE PEEP, MODEL KM-809 KOO AMERICAS, INC. 510(k) NO: K050918(TRADITIONAL)
ATTN: WILLIAM SLEVIN PHONE NO : 770-360-0911 1050-C NINE NORTH DRIVE SE DECISION MADE: 06-JUN-05 ALPHARETTA, GA 30004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANZI CLEANER SYSTEM LANGFORD IC SYSTEMS, INC. 510(k) NO: K043314(TRADITIONAL)
ATTN: TERRY LANGFORD PHONE NO : 520-745-6201 310 S. WILLIAMS BLVD. SE DECISION MADE: 20-JUN-05 SUITE 270 510(k) SUMMARY AVAILABLE FROM FDA TUCSON, AZ 85711 DEVICE: STAR 50 MONITORING SYSTEM LARSEN & TOUBRO LIMITED 510(k) NO: K051608(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 29-JUN-05 CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) LDR SPINE USA 510(k) NO: K043349(TRADITIONAL)
ATTN: BRAIN BURKINSHAW PHONE NO : 512-437-2582 4030 WEST BRAKER LANE SE DECISION MADE: 29-JUN-05 SUITE 360 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78759 DEVICE: MC+ PARTIAL VBR LDR SPINE USA 510(k) NO: K043479(TRADITIONAL)
ATTN: BRIAN BURKINSHAW PHONE NO : 512-437-4311 4030 WEST BRAKER LANE SE DECISION MADE: 30-JUN-05 SUITE 360 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78759 DEVICE: LEVO COMFORT II LEVO AG 510(k) NO: K051387(TRADITIONAL)
ATTN: MARKUS BURGER PHONE NO : 41 56 6184411 ANGLIKERSTRASSE 20 SE DECISION MADE: 10-JUN-05 P.O. BOX 1272 510(k) SUMMARY AVAILABLE FROM FDA WOHLEN, SWITZERLAND CH-5610 THIRD PARTY REVIEW DEVICE: OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTR LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K050733(TRADITIONAL)
ATTN: CHENG-I LIN PHONE NO : 408-732-3856 687 NORTH PASTORIA AVE. SE DECISION MADE: 13-JUN-05 SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K051088(TRADITIONAL)
ATTN: CHENG-I LIN PHONE NO : 408-732-3856 687 NORTH PASTORIA AVE. SE DECISION MADE: 24-JUN-05 SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INN MALLINCKRODT MEDICAL 510(k) NO: K051416(SPECIAL)
ATTN: PATRICK GARVEY PHONE NO : 925-463-4479 4280 HACIENDA DRIVE SE DECISION MADE: 16-JUN-05 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHACER; SYNTRICER MEDARTIS MEDIZINPRODUKTE UND FORSC510(k) NO: K041177(TRADITIONAL)
ATTN: HANS-PETER WETTL PHONE NO : 49 824 180456 BLUMENSTRASSE 7 SE DECISION MADE: 23-JUN-05 ALLING, GERMANY 82239 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET MEDEGEN MEDICAL MANUFACTURING SERV510(k) NO: K051499(TRADITIONAL)
ATTN: SALVADORE F PALOMARES PHONE NO : 949-463-6146 15 CHEROKEE SE DECISION MADE: 22-JUN-05 TRABUCO CANYON, CA 92679 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SONOTIP II ULTRASOUND NEEDLE SYSTEM MEDI-GLOBE CORP. 510(k) NO: K051247(SPECIAL)
ATTN: SCOTT KARLER PHONE NO : 480-897-2778 110 WEST ORION, SUITE 136 SE DECISION MADE: 16-JUN-05 TEMPE, AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICON IMF-ORION SCREWS MEDICON, E.G. 510(k) NO: K050478(TRADITIONAL)
ATTN: JOACHIM SCHMID PHONE NO : 49 746 220090 GAENSAECKER 15 SE DECISION MADE: 15-JUN-05 TUTTLINGEN, GERMANY D-78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE) MEDLINE INDUSTRIES, INC. 510(k) NO: K042164(TRADITIONAL)
ATTN: BRUCE GIBBINS PHONE NO : 503-624-9830 12232 SW GARDEN PL. SE DECISION MADE: 09-JUN-05 PORTLAND, OR 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS) MEDOC LTD. ADVANCED MEDICAL SYSTEM510(k) NO: K051448(SPECIAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116 291 HILLSIDE AVENUE SE DECISION MADE: 29-JUN-05 SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER MEDRAD, INC. 510(k) NO: K050371(TRADITIONAL)
ATTN: GEOFF M FATZINGER PHONE NO : 412-767-2400 ONE MEDRAD DR. SE DECISION MADE: 07-JUN-05 INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM MEDRAD, INC. 510(k) NO: K050456(TRADITIONAL)
ATTN: GEOFF M FATZINGER PHONE NO : 412-767-2400 ONE MEDRAD DR. SE DECISION MADE: 17-JUN-05 INDIANOLA, PA 15051 510(k) STATEMENT DEVICE: 3.0T PROSTATE IMAGING SYSTEM MEDRAD, INC. 510(k) NO: K051349(SPECIAL)
ATTN: LISA A EWING PHONE NO : 412-767-2400 ONE MEDRAD DR. SE DECISION MADE: 23-JUN-05 INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-CONSOLE, MODEL 560 MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K051303(SPECIAL)
ATTN: DAWN M STENSTROM PHONE NO : 763-391-9604 7611 NORTHLAND DR. N SE DECISION MADE: 10-JUN-05 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BASIS VERTEBRAL BODY SPACER MEDTRONIC SOFAMOR DANEK 510(k) NO: K051105(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 09-JUN-05 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K050809(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 14-JUN-05 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTERPIECE PLATE FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K050082(TRADITIONAL)
ATTN: RICHARD W TREHARNE, PHD. PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 06-JUN-05 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STELTHSTATION WIRELESS SURGEON MOUSE MEDTRONIC SURGICAL NAVIGATION 510(k) NO: K051029(SPECIAL)
ATTN: TINA DREILING PHONE NO : 720-890-3217 826 COAL CREEK CIR. SE DECISION MADE: 08-JUN-05 LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEALTHSTATION SYSTEM UPDATE MEDTRONIC SURGICAL NAVIGATION TECH510(k) NO: K050438(SPECIAL)
ATTN: TINA DREILING PHONE NO : 720-890-3217 826 COAL CREEK CIR. SE DECISION MADE: 02-JUN-05 LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER MENTOR CORP. 510(k) NO: K050008(TRADITIONAL)
ATTN: DONNA A CRAWFORD PHONE NO : 805-879-6304 201 MENTOR DRIVE SE DECISION MADE: 03-JUN-05 SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVIEW METRIKA, INC. 510(k) NO: K051321(SPECIAL)
ATTN: ERIKA B AMMIRATI PHONE NO : 408-524-2255 510 OAKMEAD PKWY. SE DECISION MADE: 13-JUN-05 SUNNYVALE, CA 94085-4022 510(k) STATEMENT DEVICE: NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR MICRO THERAPEUTICS, INC. 510(k) NO: K051425(SPECIAL)
ATTN: FLORIN TRUUVERT PHONE NO : 949-837-3700 2 GOODYEAR SE DECISION MADE: 22-JUN-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT C MICRO THERAPEUTICS, INC. 510(k) NO: K051560(SPECIAL)
ATTN: FLORIN TRUUVERT PHONE NO : 949-837-3700 2 GOODYEAR SE DECISION MADE: 28-JUN-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAS IMMUNOSUPPRESSANT CONTROLS MICROGENICS CORP. 510(k) NO: K051074(TRADITIONAL)
ATTN: LISA CHARTER PHONE NO : 510-979-5142 46360 FREMONT BLVD. SE DECISION MADE: 06-JUN-05 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. 510(k) NO: K050954(TRADITIONAL)
ATTN: VINCENT CUTARELLI PHONE NO : 949-461-3314 75 COLUMBIA SE DECISION MADE: 28-JUN-05 ALISO VIEJO, CA 92656-1408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM MISONIX, INC. 510(k) NO: K050776(TRADITIONAL)
ATTN: RONALD R MANNA PHONE NO : 631-694-9555 1938 NEW HIGHWAY SE DECISION MADE: 06-JUN-05 FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCU02 SYSTEM MITI CORP. 510(k) NO: K051007(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5600 555 13TH STREET, NW SE DECISION MADE: 16-JUN-05 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOODKNIGHT 425ST NELLCOR PURITAN BENNETT, INC. 510(k) NO: K050072(SPECIAL)
ATTN: JAMES BONDS PHONE NO : 925-463-4000 4280 HACIENDA DR. SE DECISION MADE: 13-JUN-05 PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLPUR DIALYZER, MODEL HD 190 NEPHROS, INC. 510(k) NO: K050603(TRADITIONAL)
ATTN: NADIA C GREENIDGE PHONE NO : 212-781-5113 3960 BROADWAY SE DECISION MADE: 09-JUN-05 NEW YORK, NY 10032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NICHOLS ADVANTAGE ALDOSTERONE ASSAY NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K050784(TRADITIONAL)
ATTN: XIE QIYI PHONE NO : 949-940-7358 1311 CALLE BATIDO SE DECISION MADE: 01-JUN-05 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NOBELSPEEDY IMPLANTS NOBEL BIOCARE AB 510(k) NO: K050406(TRADITIONAL)
ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 08-JUN-05 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC NOBLE FIBER TECHNOLOGIES, INC. 510(k) NO: K050649(TRADITIONAL)
ATTN: PATRICIA DAVIDSON PHONE NO : 877-978-2842 421 SOUTH STATE ST. SE DECISION MADE: 13-JUN-05 CLARKS SUMMIT, PA 18411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 2500A PALMSAT PULSE OXIMETER NONIN MEDICAL, INC. 510(k) NO: K050056(TRADITIONAL)
ATTN: LORI ROTH PHONE NO : 763-577-3166 13700 1ST AVE. NORTH SE DECISION MADE: 21-JUN-05 PLYMOUTH, MN 55441-5443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONYX II FINGER PULSE OXIMETER, MODEL 9550 NONIN MEDICAL, INC. 510(k) NO: K051107(SPECIAL)
ATTN: LORI M ROTH PHONE NO : 763-577-3093 13700 1ST AVE. NORTH SE DECISION MADE: 01-JUN-05 PLYMOUTH, MN 55441-5443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC. 510(k) NO: K050525(TRADITIONAL)
ATTN: NORMA LEMAY PHONE NO : 978-687-4700 439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 24-JUN-05 LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS NXSTAGE MEDICAL, INC. 510(k) NO: K050727(SPECIAL)
ATTN: NORMA LEMAY PHONE NO : 978-687-4746 439 SOUTH UNION ST. SE DECISION MADE: 13-JUN-05 SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA LAWRENCE, MA 01843 DEVICE: OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K050885(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 03-JUN-05 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMALL INTESTINAL VIDEOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K051551(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 28-JUN-05 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OMRON MODEL 514N TYMPANIC THERMOMETER OMRON HEALTHCARE, INC. 510(k) NO: K051233(SPECIAL)
ATTN: IWAO KOJIMA PHONE NO : 847-247-5733 1200 LAKESIDE DRIVE SE DECISION MADE: 21-JUN-05 BANNOCKBURN, IL 60015 510(k) STATEMENT DEVICE: ORLUS MINI SCREW ORTHOLUTION CO., LTD. 510(k) NO: K050568(TRADITIONAL)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909 1733 CANTON LANE SE DECISION MADE: 01-JUN-05 MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMBIBE BONE MARROW ASPIRATION NEEDLE ORTHOVITA, INC. 510(k) NO: K050795(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267-675-4611 1835 MARKET ST. 28TH FLOOR SE DECISION MADE: 03-JUN-05 PHILADELPHIA, PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYGRAFT BGS; BONE GRAFT SUBSTITUTE OSTEOBIOLOGICS, INC. 510(k) NO: K041382(TRADITIONAL) ATTN: GABRIELE G NIEDERAUER, PH.D.PHONE NO : 210-690-2131 12500 NETWORK SE DECISION MADE: 17-JUN-05 SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA SAN ANTONIO, TX 78249 DEVICE: PALOMAR LUXIR HANDPIECE PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K050370(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 919-363-2432 131 KELEKENT LN. SE DECISION MADE: 15-JUN-05 CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PENTATRASFU BLOOD TRANSFUSION SETS PENTAFERTE S.P.A 510(k) NO: K041496(ABBREVIATED)
ATTN: VICTOR PEREIRA PHONE NO : 954 608 7189 7410 NW 65TH LANE SE DECISION MADE: 30-JUN-05 PARKLAND, FL 33067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: UNICAP SPECIFIC IGE PHARMACIA DIAGNOSTICS AB 510(k) NO: K051218(SPECIAL)
ATTN: MARTIN R MANN PHONE NO : 269-492-1957 4169 COMMERCIAL AVENUE SE DECISION MADE: 09-JUN-05 PORTAGE, MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIEZOSURGERY DEVICE PIEZOSURGERY SRL 510(k) NO: K043408(TRADITIONAL)
ATTN: MARIA E DONAWA PHONE NO : 390 657 82665 PIAZZA ALBANIA 10 SE DECISION MADE: 08-JUN-05 ROME, ITALY 00153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) PLANMECA OY 510(k) NO: K051464(TRADITIONAL)
ATTN: BOB PIENKOWSKI PHONE NO : 630-529-2300 100 NORTH GARY AVE. SUITE A SE DECISION MADE: 24-JUN-05 ROSELLE, IL 60172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GRE PLATINUM GLOVE INDUSTRIES SDN.BHD.510(k) NO: K051317(TRADITIONAL)
ATTN: SO SOON CHEAW PHONE NO : 603 214 44215 4015A, FL 4,PRESIDENT HSE, SE DECISION MADE: 20-JUN-05 JLN SULTAN ISMAIL 510(k) SUMMARY AVAILABLE FROM FDA KUALA LUMPUR, MALAYSIA 50250 DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE PLATINUM GLOVE INDUSTRIES SDN.BHD.510(k) NO: K051318(TRADITIONAL)
ATTN: SO SOON CHEAW PHONE NO : 603 214 44215 4015A, FL 4,PRESIDENT HSE, SE DECISION MADE: 17-JUN-05 JLN SULTAN ISMAIL 510(k) STATEMENT KUALA LUMPUR, MALAYSIA 50250 DEVICE: SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM PRAXIM 510(k) NO: K031196(TRADITIONAL)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 07-JUN-05 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYFORM SYNTHETIC MESH PROXY BIOMEDICAL LTD. 510(k) NO: K051245(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 P.O. BOX 560 SE DECISION MADE: 17-JUN-05 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R-X-FIX EXTERNAL FIXATOR R-X-FIX 510(k) NO: K051017(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD SE DECISION MADE: 29-JUN-05 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERLING INTERFERENCE SCREW ST REGENERATION TECHNOLOGIES, INC. 510(k) NO: K050767(TRADITIONAL)
ATTN: CARRIE HARTILL PHONE NO : 386-418-8888 11621 RESEARCH CIR. SE DECISION MADE: 09-JUN-05 P.O. BOX 2650 510(k) SUMMARY AVAILABLE FROM FDA ALACHUA, FL 32616-2650 DEVICE: ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 RENAL SOLUTIONS, INC. 510(k) NO: K043574(TRADITIONAL)
ATTN: RICHARD CONFER PHONE NO : 724-772-6900 700 COMMONWEALTH DR SUITE 101 SE DECISION MADE: 03-JUN-05 WARRENDALE, PA 15086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE INCOURAGE SYSTEM RESPIRATORY TECHNOLOGIES, INCORPOR510(k) NO: K051383(TRADITIONAL)
ATTN: MARIO NOZZARELLA PHONE NO : 610-825-6700 8095 215 STREET WEST SE DECISION MADE: 17-JUN-05 LAKEVILLE, MN 55044 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MD TURBO RESPIRICS, INC. 510(k) NO: K051284(TRADITIONAL)
ATTN: EDWARD M BASILE PHONE NO : 202-626-2903 1700 PENNSYLVANIA AVENUE, N.W. SE DECISION MADE: 22-JUN-05 WASHINGTON, DC 20006-4706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIPAP AUTO RESPIRONICS, INC. 510(k) NO: K050759(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1001 MURRY RIDGE LN. SE DECISION MADE: 15-JUN-05 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FES CYCLE ERGOMETER, MODEL RT300-S RESTORATIVE THERAPIES INC. 510(k) NO: K050036(ABBREVIATED)
ATTN: ANDREW BARRISKILL PHONE NO : 310-691-5467 2363 BOSTON ST. SE DECISION MADE: 27-JUN-05 BALTIMORE, MD 21224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS RBC FOLATE HEMOLYZED REAGENT ROCHE DIAGNOSTICS CORP. 510(k) NO: K051292(SPECIAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544 9115 HAGUE RD. SE DECISION MADE: 17-JUN-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS ROEI MEDICAL TECHNOLOGIES, LTD. 510(k) NO: K050910(TRADITIONAL)
ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 16-JUN-05 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01 SCHAERER MAYFIELD USA, INC. 510(k) NO: K041897(TRADITIONAL)
ATTN: TECK AWA PHONE NO : 513-561-2241 4900 CHARLEMAR DR. SE DECISION MADE: 01-JUN-05 CINCINNATI, OH 45227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEB SCHUTZ-DENTAL GMBH 510(k) NO: K051050(TRADITIONAL)
ATTN: MICHAEL WIERZ PHONE NO : 496 003 814620 DIESELSTRASSE 5-6 SE DECISION MADE: 29-JUN-05 ROSBACH, GERMANY D-61191 510(k) STATEMENT DEVICE: ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM SCIENCE SURGICAL CORPORATION 510(k) NO: K051304(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-854-6314 3696A HAVEN AVENUE SE DECISION MADE: 03-JUN-05 REDWOOD, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CAPILLARY'S IMMUNOTYPING (PN 2100) SEBIA, INC. 510(k) NO: K042939(TRADITIONAL)
ATTN: BOREK JANIK PHONE NO : 734-475-2441 13805 WATERLOO SE DECISION MADE: 27-JUN-05 CHELSEA, MI 48118 510(k) STATEMENT DEVICE: MODIFICATION TO: SECTRA IDS5 WORKSTATION SECTRA IMTEC AB 510(k) NO: K051315(SPECIAL)
ATTN: CARL ALLETTO PHONE NO : 214-262-4209 1600 MANCHESTER WAY SE DECISION MADE: 15-JUN-05 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENTINEL CHOLINESTERASE LIQUID SENTINEL CH. SRL 510(k) NO: K051444(SPECIAL)
ATTN: DAVIDE SPADA PHONE NO : 39 02 3455141 5 VIA PRINCIPE EUGENIO SE DECISION MADE: 20-JUN-05 MILANO, ITALY 20155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERIM DIALYSATE MONITOR TEST STRIP SERIM RESEARCH CORP. 510(k) NO: K043031(TRADITIONAL)
ATTN: PATRICIA A RUPCHOCK PHONE NO : 574-264-3440 23565 REEDY DR. SE DECISION MADE: 13-JUN-05 ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A SHANGHAI LORD INTERNATIONAL TRADE 510(k) NO: K051021(ABBREVIATED)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 20-JUN-05 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES COLORED (WHITE, YEL SHIJIAZHUANG MANFUL LIGHT INDUSTRI510(k) NO: K051156(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 RM 1606, BLDG 1 JIANXIANG YUAN SE DECISION MADE: 14-JUN-05 NO 209 BIE SI HUAN ZHONG ROAD 510(k) SUMMARY AVAILABLE FROM FDA HAIDIAN DISTRICT, BEIJING, CHINA 100083 DEVICE: DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE SHIMADZU CORP. 510(k) NO: K050925(ABBREVIATED)
ATTN: RANDAL WALKER PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVE. SE DECISION MADE: 01-JUN-05 TORRANCE, CA 90502-1328 510(k) STATEMENT DEVICE: SHL DISPOSABLE AUTOINJECTOR SHL MEDICAL, USA 510(k) NO: K050434(TRADITIONAL)
ATTN: LUCIO GIAMBATTISTA PHONE NO : 973-822-3007 23 VREELAND RD., SE DECISION MADE: 24-JUN-05 SUITE 104 510(k) SUMMARY AVAILABLE FROM FDA FLORHAM PARK, NJ 07932 DEVICE: ARCADIS AVANTIC SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K051133(TRADITIONAL)
ATTN: MICHAEL J ANDREWS PHONE NO : 610-448-4599 51 VALLEY STREAM PARKWAY, E-50 SE DECISION MADE: 01-JUN-05 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALLOS IMPACT AND INJECT BONE VOID FILLER SKELETAL KINETICS, LLC 510(k) NO: K051123(SPECIAL)
ATTN: DURAN YETKINLER PHONE NO : 408-366-5002 10201 BUBB RD. SE DECISION MADE: 03-JUN-05 CUPERTINO, CA 95014-4167 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVITALIGHT SKIN CARE SYSTEM SKINCARE TECHNOLOGY INC. 510(k) NO: K042630(TRADITIONAL)
ATTN: RICHARD O WOOD PHONE NO : 312-807-4364 70 W MADISON ST., SUITE 3300 SE DECISION MADE: 27-JUN-05 CHICAGO, IL 60602 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100I SKYLARK DEVICE & SYSTEMS CO., LTD 510(k) NO: K043306(TRADITIONAL)
ATTN: BETTY CHIEN PHONE NO : 022 597 9001 4F, 34, SEC. 3, SE DECISION MADE: 06-JUN-05 CHUNG SHAN NORTH RD. 510(k) STATEMENT TAIPEI, CHINA (TAIWAN) DEVICE: SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K051326(TRADITIONAL)
ATTN: JANICE HASELTON PHONE NO : 978-749-1494 150 MINUTEMAN RD. SE DECISION MADE: 15-JUN-05 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS SMITH & NEPHEW, INC. 510(k) NO: K051557(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487 1450 E. BROOKS RD. SE DECISION MADE: 30-JUN-05 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RIVA LIGHT CURE SOUTHERN DENTAL INDUSTRIES, INC. 510(k) NO: K050870(TRADITIONAL)
ATTN: RAY CAHILL PHONE NO : 630-238-8300 5 BRUNSDON ST 3125 SE DECISION MADE: 03-JUN-05 BAYSWATER VI 3125, AUSTRALIA 510(k) STATEMENT DEVICE: RIVA PROTECT SOUTHERN DENTAL INDUSTRIES, INC. 510(k) NO: K050871(TRADITIONAL)
ATTN: RAY CAHILL PHONE NO : 630-238-8300 5 BRUNSDON ST 3125 SE DECISION MADE: 10-JUN-05 BAYSWATER VI 3125, AUSTRALIA 510(k) STATEMENT DEVICE: SET SOUTHERN DENTAL INDUSTRIES, LTD. 510(k) NO: K051008(TRADITIONAL)
ATTN: RAY CAHILL PHONE NO : 630-238-8300 729 N. ROUTE 83, SUITE 315 SE DECISION MADE: 15-JUN-05 BENSENVILLE, IL 60106 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR STANBIO LABORATORY 510(k) NO: K050266(TRADITIONAL)
ATTN: KIRK JOHNSON PHONE NO : 830-249-0772 1261 NORTH MAIN ST. SE DECISION MADE: 30-JUN-05 BOERNE, TX 78006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CREATININE LIQUICOLOR STANBIO LABORATORY 510(k) NO: K050283(TRADITIONAL)
ATTN: KIRK JOHNSON PHONE NO : 830-249-0772 1261 NORTH MAIN ST. SE DECISION MADE: 30-JUN-05 BOERNE, TX 78006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIODRIVE CATHETER ADVANCEMENT SYSTEM STEREOTAXIS, INC. 510(k) NO: K051374(SPECIAL)
ATTN: KELLY ROWLAND PHONE NO : 314-633-5022 4041 FOREST PARK AVE. SE DECISION MADE: 23-JUN-05 ST. LOUIS, MO 63108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS STERILMED, INC. 510(k) NO: K051220(TRADITIONAL)
ATTN: BRUCE R LESTER PHONE NO : 888-856-4870 11400 73RD AVE. NORTH, #100 SE DECISION MADE: 14-JUN-05 MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTECT TOOTH DESENSITIZER SUNSTAR BUTLER 510(k) NO: K050486(TRADITIONAL)
ATTN: RICHARD O WOOD PHONE NO : 312-807-4364 70 W. MADISON ST., SUITE 3300 SE DECISION MADE: 07-JUN-05 CHICAGO, IL 60602 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STALIF TT SURGICRAFT LTD. 510(k) NO: K051027(TRADITIONAL)
ATTN: JANET M WEBB PHONE NO : 312-643-1206 950 N MICHIGAN AVE. #2202 SE DECISION MADE: 29-JUN-05 CHICAGO, IL 60611 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE SUTURES INDIA PRIVATE LIMITED 510(k) NO: K041510(TRADITIONAL)
ATTN: L.G. CHANDRASEKHAR PHONE NO : 918 028 395150 118, 3RD PHASE SE DECISION MADE: 02-JUN-05 PEENYA INDUSTRIAL AREA 510(k) SUMMARY AVAILABLE FROM FDA BANGALORE, INDIA 560-058 DEVICE: TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE SUTURES INDIA PRIVATE LIMITED 510(k) NO: K041511(TRADITIONAL)
ATTN: L.G. CHANDRASEKHAR PHONE NO : 918 028 395150 118, 3RD PHASE SE DECISION MADE: 03-JUN-05 PEENYA INDUSTRIAL AREA 510(k) SUMMARY AVAILABLE FROM FDA BANGALORE, INDIA 560-058 DEVICE: NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE SUTURES INDIA PRIVATE LIMITED 510(k) NO: K041512(TRADITIONAL)
ATTN: L.G. CHANDRASEKHAR PHONE NO : 918 028 395150 118, 3RD PHASE SE DECISION MADE: 02-JUN-05 PEENYA INDUSTRIAL AREA 510(k) SUMMARY AVAILABLE FROM FDA BANGALORE, INDIA 560-058 DEVICE: TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE SUTURES INDIA PRIVATE LIMITED 510(k) NO: K041514(TRADITIONAL)
ATTN: L.G. CHANDRASEKHAR PHONE NO : 918 028 395150 118, 3RD PHASE SE DECISION MADE: 03-JUN-05 PEENYA INDUSTRIAL AREA 510(k) SUMMARY AVAILABLE FROM FDA BANGALORE, INDIA 560-058 DEVICE: VARELISA RECOMBI CTD SCREEN, MODEL 13096 SWEDEN DIAGNOSTICS (GERMANY) GMBH 510(k) NO: K050967(TRADITIONAL)
ATTN: MICHAEL LINSS PHONE NO : 497 614 7805310 MUNZINGER STRASSE 7 SE DECISION MADE: 28-JUN-05 FREIBURG, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VELASMOOTH, SHAPER SYNERON MEDICAL LTD. 510(k) NO: K050397(TRADITIONAL)
ATTN: DONALD E SEGAL PHONE NO : 202-756-3333 601 PENNSYLVANIA AVE., N.W. SE DECISION MADE: 09-JUN-05 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MENDEC SPINE TECRES SPA 510(k) NO: K042415(TRADITIONAL)
ATTN: CHRISTINE BRAUER PHONE NO : 301-545-1990 ONE DEMOCRACY PLAZA SE DECISION MADE: 09-JUN-05 6701 DEMOCRACY BLVD. STE. 700 510(k) SUMMARY AVAILABLE FROM FDA BETHESDA, MD 20817 DEVICE: XENFORM SOFT TISSUE REPAIR MATRIX TEI BIOSCIENCES INC. 510(k) NO: K051190(SPECIAL)
ATTN: KENNETH JAMES PHONE NO : 617-268-1616 7 ELKINS ST. SE DECISION MADE: 10-JUN-05 BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDER TERANG NUSA SDN BHD 510(k) NO: K051094(SPECIAL)
ATTN: LOW CHIN GUAN PHONE NO : 609 774 7171 1, JALAN 8, SE DECISION MADE: 06-JUN-05 PENGKALAN CHEPA 2 IND. ZONE 510(k) SUMMARY AVAILABLE FROM FDA KOTA BHARU, KELANTAN, MALAYSIA 16100 DEVICE: NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES P TERANG NUSA SDN BHD 510(k) NO: K051563(SPECIAL)
ATTN: CHIN-GUAN LOW PHONE NO : 60 9 7747171 1, JALAN 8, SE DECISION MADE: 20-JUN-05 PENGKALAN CHEPA 2 IND. ZONE 510(k) STATEMENT KOTA BHARU, KELANTAN, MALAYSIA 16100 DEVICE: TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER TERATECH CORP. 510(k) NO: K051334(TRADITIONAL)
ATTN: CHARLES F HOTTINGER PHONE NO : 206-780-7945 PO BOX 10074 SE DECISION MADE: 03-JUN-05 13221 NE TEEM LOOP ROAD 510(k) SUMMARY AVAILABLE FROM FDA BAINBRIDGE ISLAND, WA 98110 THIRD PARTY REVIEW DEVICE: FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM THERASENSE, INC. 510(k) NO: K050500(TRADITIONAL)
ATTN: KIMBERLEY KLINE PHONE NO : 510-749-5478 1360 SOUTH LOOP RD. SE DECISION MADE: 27-JUN-05 ALAMEDA, CA 94502-7000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A THERATECH, INC. 510(k) NO: K050847(SPECIAL)
ATTN: MICHAEL PRICE PHONE NO : 615-865-4000 1109 MYATT BLVD. SE DECISION MADE: 17-JUN-05 MADISON, TN 37115 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPI DENTAL IMPLANT THOMMEN MEDICAL, AG 510(k) NO: K051502(SPECIAL)
ATTN: FLOYD LARSON PHONE NO : 858-792-1235 11234 EL CAMINO REAL, STE. 200 SE DECISION MADE: 21-JUN-05 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPERCATH Z3V TOGO MEDIKIT CO., LTD. 510(k) NO: K050114(TRADITIONAL)
ATTN: KOZO NAGAYAMAB PHONE NO : 81 982 538000 17148-6 OAZA-HICHIYA AZA- SE DECISION MADE: 09-JUN-05 KAMEKAWA,HYUGA-SHI, 510(k) SUMMARY AVAILABLE FROM FDA MIYAZAKI-KEN, JAPAN 883-0062 DEVICE: EYE CUP, STERILE 1 AND NON STERILE TOLLOT PTY LTD. 510(k) NO: K051414(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 16-JUN-05 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K051500(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 17-JUN-05 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: 19-INCH (48 CM) COLOR LCD MONITOR CDL1902A TOTOKU ELECTRIC CO., LTD 510(k) NO: K051331(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : +81 268 345469 300 OYA SE DECISION MADE: 27-JUN-05 UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANS1 AXIALIF SYSTEM TRANS1 INCORPORATED 510(k) NO: K050965(TRADITIONAL)
ATTN: ROBERT L SHERIDAN PHONE NO : 910-509-3100 1800 SIR TYLER DRIVE SE DECISION MADE: 14-JUN-05 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA WILMINGTON, NC 28405 DEVICE: ZENO TYRELL, INC. 510(k) NO: K043377(TRADITIONAL)
ATTN: DARLA J ELKIN PHONE NO : 281-367-6655 2202 TIMBERLOCH PLACE SE DECISION MADE: 01-JUN-05 SUITE 230 510(k) SUMMARY AVAILABLE FROM FDA THE WOODLANDS, TX 77380 DEVICE: MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE UNITED STATES SURGICAL, A DIVISION510(k) NO: K050947(SPECIAL)
ATTN: SHARON L MURPHY PHONE NO : 203-845-1386 150 GLOVER AVE. SE DECISION MADE: 01-JUN-05 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPEN BREAST COIL (OBC) WITH BIOPSY PLATES USA INSTRUMENTS, INC. 510(k) NO: K050728(SPECIAL)
ATTN: DAVID BROWN PHONE NO : 330-995-8572 1515 DANNER DR. SE DECISION MADE: 28-JUN-05 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K050763(TRADITIONAL)
ATTN: HEATHER CRAWFORD PHONE NO : 863-583-8680 5307 GREAT OAK DR. SE DECISION MADE: 01-JUN-05 LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K051043(TRADITIONAL)
ATTN: HEATHER CRAWFORD PHONE NO : 863-904-2250 5307 GREAT OAK DR. SE DECISION MADE: 06-JUN-05 LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ON TRAK TESTCARD VARIAN INC 510(k) NO: K051235(SPECIAL)
ATTN: LORNA GAMBOA PHONE NO : 949-770-9381 25200 COMMERCENTRE DR. SE DECISION MADE: 08-JUN-05 LAKE FOREST, CA 92630-8810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER VASCULAR SOLUTIONS, INC. 510(k) NO: K051395(TRADITIONAL)
ATTN: SARA L COON PHONE NO : 763-656-4399 6464 SYCAMORE COURT NORTH SE DECISION MADE: 24-JUN-05 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ SMART VIP DIAGNOSTICS LLC 510(k) NO: K043340(TRADITIONAL)
ATTN: DAVID L ROSEN PHONE NO : 202-861-3881 1200 19TH ST. NW SE DECISION MADE: 02-JUN-05 WASHINGTON, DC 20036-2412 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCU VITAID, LTD. 510(k) NO: K050803(TRADITIONAL)
ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 30-JUN-05 MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO:REGISTRADO X-TRA VOCO GMBH 510(k) NO: K051535(SPECIAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 28-JUN-05 BEND, OR 97702 510(k) STATEMENT DEVICE: REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER VOLCANO CORPORATION 510(k) NO: K050995(SPECIAL)
ATTN: LORRY HUFFMAN PHONE NO : 916-638-9404 2870 KILGORE RD. SE DECISION MADE: 20-JUN-05 RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE W.L. GORE & ASSOCIATES, INC. 510(k) NO: K051267(TRADITIONAL)
ATTN: JACQUELINE KALBACH PHONE NO : 928-864-3731 3450 WEST KILTIE LANE, SE DECISION MADE: 15-JUN-05 P.O.BOX 500 510(k) SUMMARY AVAILABLE FROM FDA FLAGSTAFF, AZ DEVICE: WAGNER STERISET STERILIZATION CONTAINER WAGNER GMBH 510(k) NO: K041096(TRADITIONAL)
ATTN: LARA N SIMMONS PHONE NO : 847-682-0224 22411 60TH STREET SE DECISION MADE: 03-JUN-05 BRISTOL, WI 53104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAVELIGHT AURIGA WAVELIGHT LASER TECHNOLOGIE AG 510(k) NO: K051399(TRADITIONAL)
ATTN: ALEXANDER POPP PHONE NO : 011 499 1316186121 AM WOLFSMANTEL 5 SE DECISION MADE: 30-JUN-05 ERLANGEN, GERMANY 91058 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: XAWEX G 100 WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K050903(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 072 313705219 SCHWENNINGER STRASSE 13 SE DECISION MADE: 23-JUN-05 PFORZHEIM, GERMANY 75179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ZIBO SINOCARE PLASTIC PRODUCTS CO.510(k) NO: K051148(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 209 BEI SI HUAN ZHONG ROAD SE DECISION MADE: 21-JUN-05 HAIDIAN DISTRICT, BLDG. 1 510(k) SUMMARY AVAILABLE FROM FDA BEIJING, CHINA 100083 DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) ZIBO SINOCARE PLASTIC PRODUCTS CO.510(k) NO: K051152(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 209 BEI SI HUAN ZHONG ROAD SE DECISION MADE: 03-JUN-05 HAIDIAN DISTRICT, BLDG. 1 510(k) SUMMARY AVAILABLE FROM FDA BEIJING, CHINA 100083 DEVICE: TRABECULAR METAL PRIMARY HIP PROSTHESIS ZIMMER, INC. 510(k) NO: K051491(SPECIAL)
ATTN: DALENE T BINKLEY PHONE NO : 574-372-4907 P.O. BOX 708 SE DECISION MADE: 30-JUN-05 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL M SERIES 12SL ANALYSIS OPTION ZOLL MEDICAL CORPORATION 510(k) NO: K051475(SPECIAL)
ATTN: SEAN REYNOLDS PHONE NO : 978-421-9386 269 MILL ROAD SE DECISION MADE: 24-JUN-05 CHELMSFORD, MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 263 TOTAL WITH SUMMARIES 240 TOTAL WITH STATEMENTS 23
Updated July 5, 2005
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