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510(k)s Final Decisions Rendered for June 2005 |
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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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