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Medical Devices
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February 2005 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-FEB-2005 THROUGH 28-FEB-2005
DEVICE: SONALIS, MODEL 2000
3G ULTRASOUND, INC. 510(k) NO: K043189(ABBREVIATED)
ATTN: PAUL SCHNEIDER PHONE NO : 561-638-7108
12672 CORAL LAKES DRIVE SE DECISION MADE: 09-FEB-05
BOYNTON BEACH, FL 33437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
3M COMPANY 510(k) NO: K050159(SPECIAL)
ATTN: GINGER CANTOR PHONE NO : 651-736-2101
3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 22-FEB-05
ST. PAUL, MN 55133-3275 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
ABBOT LABORATORIES 510(k) NO: K050103(SPECIAL)
ATTN: ANN E LEONARD PHONE NO : 650-474-3477
400 SAGINAW DR. SE DECISION MADE: 16-FEB-05
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
ACON LABORATORIES, INC. 510(k) NO: K042272(TRADITIONAL)
ATTN: EDWARD TUNG, PH.D. PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 28-FEB-05
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE
ACON LABORATORIES, INC. 510(k) NO: K043507(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 25-FEB-05
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED ACUMEN SHEATH, MODEL TTWO767
ACUMEN MEDICAL, INC. 510(k) NO: K050015(SPECIAL)
ATTN: MARYBETH GAMBER PHONE NO : 774-249-5250
1400 TERRA BELLA BLVD. SE DECISION MADE: 03-FEB-05
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94043
DEVICE: ASSIST HEADER CLEANER
ALCAVIS INTERNATIONAL, INC. 510(k) NO: K043126(TRADITIONAL)
ATTN: GARY J MISHKIN PHONE NO : 301-330-7597
8-8 METROPOLITAN CT. SE DECISION MADE: 03-FEB-05
GAITHERSBURG, MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROC LUMBAR PLATING SYSTEM
ALPHATEC/NEXMED 510(k) NO: K050078(TRADITIONAL)
ATTN: ELLEN A YARNALL PHONE NO : 760-431-9286
6110 CORTE DEL CEDRO SE DECISION MADE: 18-FEB-05
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANOSS BONE VOID FILLER
ANGSTROM MEDICA, INC. 510(k) NO: K050025(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 03-FEB-05
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX MEDICAL MININEB & MINIPLUS
APEX MEDICAL CORP. 510(k) NO: K050104(SPECIAL)
ATTN: ANAN CHANG PHONE NO : 886 222 683100
NO. 9, MINSHENG STREET SE DECISION MADE: 16-FEB-05
TUCHENG CITY, TAIPEI COUNTY, CHINA510(k) STATEMENT
DEVICE: APEX MODULAR HA HIP STEM
APEX SURGICAL, LLC. 510(k) NO: K043123(TRADITIONAL)
ATTN: EDWARD J CHEAL PHONE NO : 508-947-6500
12 HARDING STREET,SUITE 202 SE DECISION MADE: 10-FEB-05
LAKEVILLE, MA 02347 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS
ARKRAY, INC. 510(k) NO: K050077(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 206-262-7363
510 FURNACE DOCK RD. SE DECISION MADE: 15-FEB-05
CORTLANDT MANOR, NY 10567 510(k) STATEMENT
DEVICE: ENDOASSIST
ARMSTRONG HEALTHCARE LIMITED 510(k) NO: K043284(TRADITIONAL)
ATTN: PATRICK A FINLAY PHONE NO : 441 628 536900
KNAVES BEECH BUSINESS CENTRE SE DECISION MADE: 25-FEB-05
LOUDWATER 510(k) SUMMARY AVAILABLE FROM FDA
HIGH WYCOMBE, UNITED KINGDOM HP10 9QR
DEVICE: BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B
ARTHREX, INC. 510(k) NO: K043145(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 18-FEB-05
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STA
ARTHREX, INC. 510(k) NO: K043248(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 239-643-5539
1370 CREEKSIDE BLVD. SE DECISION MADE: 16-FEB-05
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIS SRS (SEMI-RESUABLE SENSOR)
ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K050313(TRADITIONAL)
ATTN: CHRISTINE VOZELLA PHONE NO : 303-926-5624
141 NEEDHAM ST. SE DECISION MADE: 24-FEB-05
NEWTON, MA 02464 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PROSTATE-63 CANCER DIAGNOSTIC TEST
ASYMMETRX 510(k) NO: K050063(TRADITIONAL)
ATTN: MARIA MCKEON PHONE NO : 860-716-8888
117 SENATE BROOK DR. SE DECISION MADE: 09-FEB-05
AMSTON, CT 06231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRELLIS-8 PERIPHERAL INFUSION SYSTEM
BACCHUS VASCULAR, INC. 510(k) NO: K050147(SPECIAL)
ATTN: MAUREEN BENSING PHONE NO : 408-980-8300
3110 CORONADO DR. SE DECISION MADE: 03-FEB-05
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA IMS VALPROIC ACID METHOD
BAYER HEALTHCARE, LLC 510(k) NO: K042807(TRADITIONAL)
ATTN: ANDRES HOLLE PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 08-FEB-05
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA IMS CARBAMAZEPINE METHOD
BAYER HEALTHCARE, LLC 510(k) NO: K042808(TRADITIONAL)
ATTN: ANDRES HOLLE PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 08-FEB-05
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEAMCATH
BEAMPOINT AB 510(k) NO: K042110(TRADITIONAL)
ATTN: CONSTANCE BUNDY PHONE NO : 763-574-1976
6740 RIVERVIEW TERRACE SE DECISION MADE: 25-FEB-05
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COULTER LH 750 HEMATOLOGY ANALYZER
BECKMAN COULTER, INC. 510(k) NO: K050057(SPECIAL)
ATTN: STAN SUGRUE PHONE NO : 305-380-4552
11800 SW 147TH AVE. SE DECISION MADE: 10-FEB-05
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYST
BECKMAN COULTER, INC. 510(k) NO: K050202(SPECIAL)
ATTN: BRENT TABER PHONE NO : 952-368-1232
1000 LAKE HAZELTINE DR. SE DECISION MADE: 09-FEB-05
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEMIFLOXACIN, 5UG BBL SENSI-DISC
BECTON DICKINSON & CO. 510(k) NO: K050062(TRADITIONAL)
ATTN: BRADFORD SPRING PHONE NO : 410-316-4206
7 LOVETON CIR. SE DECISION MADE: 10-FEB-05
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL S
BECTON DICKINSON & CO. 510(k) NO: K050191(SPECIAL)
ATTN: CARTER NAVARRO PHONE NO : 408-954-2469
2350 QUME DRIVE SE DECISION MADE: 22-FEB-05
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM
BECTON, DICKINSON & CO. 510(k) NO: K050089(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 28-FEB-05
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL SC-3008 SEQUENTIAL CIRCULATOR
BIO COMPRESSION SYSTEMS, INC. 510(k) NO: K043423(TRADITIONAL)
ATTN: RON MOTHERWELL PHONE NO : 201-939-0716
120 WEST COMMERCIAL AVE. SE DECISION MADE: 01-FEB-05
MOONACHIE, NJ 07074 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LIQUICHEK BNP CONTROL
BIO-RAD LABORATORIES, INC. 510(k) NO: K043584(TRADITIONAL)
ATTN: SUZANNE S PARSONS PHONE NO : 949-598-1467
9500 JERONIMO RD. SE DECISION MADE: 08-FEB-05
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER
BIOCARDIA, INC. 510(k) NO: K042553(TRADITIONAL)
ATTN: DANIEL C ROSENMAN PHONE NO : 650-624-0900
384 OYSTER POINT BLVD. SE DECISION MADE: 17-FEB-05
SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 COMPACT
BIOMERIEUX, INC. 510(k) NO: K050002(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM DR. SE DECISION MADE: 17-FEB-05
HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 GRAM POSITIVE DAPTOMYCIN
BIOMERIEUX, INC. 510(k) NO: K050075(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386
595 ANGLUM RD. SE DECISION MADE: 28-FEB-05
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 GRAM POSITIVE ERTAPENEM
BIOMERIEUX, INC. 510(k) NO: K050076(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386
595 ANGLUM RD. SE DECISION MADE: 18-FEB-05
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER
BIOMERIX CORPORATION 510(k) NO: K043371(TRADITIONAL)
ATTN: CHRISTINA L KICHULA PHONE NO : 301-998-6151
1700 ROCKVILLE PIKE SE DECISION MADE: 03-FEB-05
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILE, MD 20852
DEVICE: VANGUARD SSK KNEE SYSTEM
BIOMET, INC. 510(k) NO: K042757(TRADITIONAL)
ATTN: GARY BAKER PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 11-FEB-05
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLEN
BIOMET, INC. 510(k) NO: K043100(SPECIAL)
ATTN: GARY BAKER PHONE NO : 574-372-1568
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 17-FEB-05
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
BIOMET, INC. 510(k) NO: K043505(TRADITIONAL)
ATTN: GARY BAKER PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 09-FEB-05
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANAL
BIONOSTICS, INC. 510(k) NO: K050100(TRADITIONAL)
ATTN: KATHY STORRO PHONE NO : 978-772-7070
7 JACKSON RD. SE DECISION MADE: 25-FEB-05
DEVENS, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIAGE TOX DRUG SCREEN
BIOSITE INCORPORATED 510(k) NO: K043242(TRADITIONAL)
ATTN: JEFFREY R DAHLEN PHONE NO : 858-455-4808
11030 ROSELLE ST. SE DECISION MADE: 28-FEB-05
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WIT
BIOTEQUE CORP. 510(k) NO: K033862(TRADITIONAL)
ATTN: WILLIAM LEE PHONE NO : 886 2 27083188
8F-3, NO. 136, SEC. 3, SE DECISION MADE: 14-FEB-05
JEN-AI ROAD 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN)
DEVICE: TESCERA OPAQUER POWDER/SCULPTING RESIN
BISCO, INC. 510(k) NO: K042804(TRADITIONAL)
ATTN: BENJAMIN LICHTENWALNER PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 01-FEB-05
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BISCOVER LV
BISCO, INC. 510(k) NO: K043168(TRADITIONAL)
ATTN: BENJAMIN LICHTENWALNER PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 01-FEB-05
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLAKSTONE LAMINOPLASTY FIXATION SYSTEM
BLACKSTONE MEDICAL, INC. 510(k) NO: K043338(TRADITIONAL)
ATTN: DEAN CIPORKIN PHONE NO : 413-726-2513
90 BROOKSDALE DR. SE DECISION MADE: 18-FEB-05
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY CORE BIOPSY SYSTEM II
BOSTON SCIENTIFIC CORP. 510(k) NO: K050120(SPECIAL)
ATTN: MICHELLE M BERRY PHONE NO : 508-652-5941
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 08-FEB-05
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORVISION OSTEOTOMY
BRAINLAB AG 510(k) NO: K042513(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 10-FEB-05
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
C.R. BARD, INC. 510(k) NO: K043246(TRADITIONAL)
ATTN: JOHN C KNORPP PHONE NO : 770-784-6451
8195 INDUSTRIAL BLVD SE DECISION MADE: 02-FEB-05
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM,
CANDELA CORP. 510(k) NO: K043251(TRADITIONAL)
ATTN: LORRAINE CALZETTA PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 09-FEB-05
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TURBO TEMP TRIO
CARDINAL HEALTH, ALARIS PRODUCTS 510(k) NO: K050230(TRADITIONAL)
ATTN: STACY L LEWIS PHONE NO : 858-458-7830
10221 WATERIDGE CIRCLE SE DECISION MADE: 16-FEB-05
SAN DIEGO, CA 92121-2772 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DERMILLUME, MODEL PRO1000
CARE ELECTRONICS, INC. 510(k) NO: K043575(TRADITIONAL)
ATTN: THOMAS MOODY PHONE NO : 303-444-2273
4700 STERLING DR., SUITE D SE DECISION MADE: 24-FEB-05
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISCUCAM C DIGITAL CAMERA
CARL ZEISS MEDITEC AG 510(k) NO: K043222(TRADITIONAL)
ATTN: R. MICHAEL CROMPTON PHONE NO : 925-557-4353
5160 HACIENDA DRIVE SE DECISION MADE: 14-FEB-05
DUBLIN, CA 94568-7562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE
CHISON MEDICAL IMAGING CO., LTD. 510(k) NO: K050167(TRADITIONAL)
ATTN: MO RUOLI PHONE NO : 86 510 5219043
NO. 8, XIANG NAN ROAD SE DECISION MADE: 08-FEB-05
SHUO FANG, NEW DISTRICT 510(k) STATEMENT
WUXI, CHINA 214142 THIRD PARTY REVIEW
DEVICE: RETRACTOFOAM
COLTENE/WHALEDENT AG 510(k) NO: K050013(TRADITIONAL)
ATTN: HENRY J VOGELSTEIN PHONE NO : 212-289-4748
1349 LEXINGTON AVENUE SE DECISION MADE: 09-FEB-05
NEW YORK, NY 10128 510(k) STATEMENT
DEVICE: SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE E
CONMED ELECTROSURGERY 510(k) NO: K050161(SPECIAL)
ATTN: PAMELA VETTER PHONE NO : 303-699-7600
14603 E. FREMONT AVE. SE DECISION MADE: 03-FEB-05
CENTENNIAL, CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSCOPE 3-STAGE BALLOON DILATOR
CORDIS EUROPA, N.V. 510(k) NO: K043605(TRADITIONAL)
ATTN: HARM HOVINGA PHONE NO : 315 050 22479
OOSTEINDE 8 SE DECISION MADE: 04-FEB-05
RODEN, NETHERLANDS NL-9301 LJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
DADE BEHRING, INC. 510(k) NO: K042735(TRADITIONAL)
ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 15-FEB-05
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR,
DADE BEHRING, INC. 510(k) NO: K043476(TRADITIONAL)
ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798
GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 15-FEB-05
BLDG 500, MS 514 P.O.BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (
DADE BEHRING, INC. 510(k) NO: K043545(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
2040 ENTERPRISE BLVD. SE DECISION MADE: 17-FEB-05
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM
DADE MICROSCAN, INC. 510(k) NO: K043589(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
1584 ENTERPRISE BLVD. SE DECISION MADE: 14-FEB-05
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAKOCYTOMATION ER/PR PHARMDX KIT
DAKOCYTOMATION CALIFORNIA, INC. 510(k) NO: K042884(TRADITIONAL)
ATTN: TIFFANY D ALMEROTH PHONE NO : 805-566-6655
6392 VIA REAL SE DECISION MADE: 15-FEB-05
CARPINTERIA, CA 93013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELLIPSE LIGHT SPT
DANISH DERMATOLOGIC DEVELOPMENT A/510(k) NO: K043255(TRADITIONAL)
ATTN: OLE KOFOD PHONE NO : 45 451 76863
AGERN ALLE 11 SE DECISION MADE: 24-FEB-05
HORSHOLM, DENMARK 2970 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MOD
DATEX-OHMEDA 510(k) NO: K043551(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM RD. SE DECISION MADE: 18-FEB-05
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPATIBILITY ECG TRUNK CABLES
DATEX-OHMEDA 510(k) NO: K043572(TRADITIONAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM RD. SE DECISION MADE: 22-FEB-05
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
DATEX-OHMEDA, INC. 510(k) NO: K050055(SPECIAL)
ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551
P.O. BOX 7550 SE DECISION MADE: 04-FEB-05
MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHES
DENTSPLY INTERNATIONAL 510(k) NO: K050386(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 W. PHILADELPHIA ST. SE DECISION MADE: 23-FEB-05
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: CORAIL AMT HIP PROSTHESIS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K042992(TRADITIONAL)
ATTN: NANCY S FRIDDLE PHONE NO : 574-371-4923
700 ORTHOPAEDIC DR. SE DECISION MADE: 11-FEB-05
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: MODIFICATION TO: HEALOS BONE GRAFT MATERIAL
DEPUY SPINE, INC. 510(k) NO: K043308(SPECIAL)
ATTN: SHARON STAROWICZ PHONE NO : 508-828-2867
325 PARAMOUNT DR. SE DECISION MADE: 16-FEB-05
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMOND MEDISTIM
DIAMOND SYSTEMS USA, INC. 510(k) NO: K041390(TRADITIONAL)
ATTN: DONNA LOPE PHONE NO : 973-458-1221
UNIT C, 1 MADISON ST SE DECISION MADE: 09-FEB-05
EAST RUTHERFORD, NJ 07073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENO
DIDECO S.R.L. 510(k) NO: K043323(ABBREVIATED)
ATTN: BARRY SALL PHONE NO : 781-434-4742
195 WEST ST. SE DECISION MADE: 01-FEB-05
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM
DIPPED PRODUCTS (THAILAND) LTD 510(k) NO: K050152(TRADITIONAL)
ATTN: IAN P GORDON PHONE NO : 727-797-4727
2454 MCMULLEN BOOTH ROAD SE DECISION MADE: 07-FEB-05
SUITE 427 510(k) SUMMARY AVAILABLE FROM FDA
CLEARWATER, FL 33759 THIRD PARTY REVIEW
DEVICE: CUSTODIOL
DR. FRANZ KOHLER CHEMIE GMBH 510(k) NO: K043461(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-570-0013
2305 GOLD MINE RD. SE DECISION MADE: 28-FEB-05
BROOKEVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY KAPPA XLT
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K042904(TRADITIONAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 18-FEB-05
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DE
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K043439(TRADITIONAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 18-FEB-05
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUOPROSS SYRINGES
DUOPROSS MEDITECH CORPORATION 510(k) NO: K042500(TRADITIONAL)
ATTN: FRANK FREGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 22-FEB-05
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: EBI TROCHANTERIC NAIL SYSTEM
EBI, L.P. 510(k) NO: K050118(TRADITIONAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 16-FEB-05
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
EFRATGO, LTD. HI TECH BIO-SURGICAL510(k) NO: K043233(TRADITIONAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116
291 HILLSIDE AVE. SE DECISION MADE: 01-FEB-05
SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOCHROME LCD MONITOR, RADIFORCE G51
EIZO NANAO CORPORATION 510(k) NO: K042755(TRADITIONAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 81 76 2742468
153 SHIMOKASHIWANO-CHO SE DECISION MADE: 10-FEB-05
MATTO-SHI 510(k) SUMMARY AVAILABLE FROM FDA
ISHIKAWA-KEN, JAPAN 924-8566
DEVICE: EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER
EMMEBI SRL 510(k) NO: K043446(TRADITIONAL)
ATTN: MARJORIE BUSH PHONE NO : 616-957-1677
6064 PARVIEW SE SE DECISION MADE: 04-FEB-05
GRAND RAPID, MI 49546 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM
ENDOCARE, INC. 510(k) NO: K050347(TRADITIONAL)
ATTN: EBEN GORDON PHONE NO : 949-450-5424
201 TECHNOLOGY DR. SE DECISION MADE: 25-FEB-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS
ENVITEC-WISMAR GMBH 510(k) NO: K043463(TRADITIONAL)
ATTN: STEPHEN GORSKI PHONE NO : 262-594-2114
S65 W35739 PIPER RD SE DECISION MADE: 11-FEB-05
EAGLE, WI 53119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM
EP TECHNOLOGIES, INC. 510(k) NO: K043257(SPECIAL)
ATTN: TODD G BRILL PHONE NO : 408-895-3564
2710 ORCHARD PKWY. SE DECISION MADE: 03-FEB-05
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350
ESAOTE, S.P.A. 510(k) NO: K050326(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 28-FEB-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH
FACILE MEDICAL, INC. 510(k) NO: K042308(TRADITIONAL)
ATTN: ALBERT REGO PHONE NO : 949-770-8710
27001 LA PAZ SE DECISION MADE: 17-FEB-05
SUITE 312 510(k) SUMMARY AVAILABLE FROM FDA
MISSION VIEJO, CA 92691
DEVICE: FERRIS POLYMEM STERILE BREAST PAD
FERRIS MFG. CORP. 510(k) NO: K031660(TRADITIONAL)
ATTN: THEODORE R THORSEN PHONE NO : 630-734-7830
16W300 83RD ST. SE DECISION MADE: 22-FEB-05
BURR RIDGE, IL 60527-5848 510(k) STATEMENT
DEVICE: FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
FIRST QUALITY HYGIENIC, INC. 510(k) NO: K050067(TRADITIONAL)
ATTN: ROBERT J STAAB, PH.D. PHONE NO : 301-327-0035
73 FRANKLIN TURNPIKE SE DECISION MADE: 01-FEB-05
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOOTHILLS SURGICAL DRAPES
FOOTHILLS INDUSTRIES, INC. 510(k) NO: K041224(TRADITIONAL)
ATTN: JOY SHUFORD PHONE NO : 828-652-4088
172 LUKIN ST. SE DECISION MADE: 03-FEB-05
MARION, NC 28752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800
FOX HOLLOW TECHNOLOGIES 510(k) NO: K043553(SPECIAL)
ATTN: MELISSA MURPHY PHONE NO : 650-421-8579
300 SAGINAW DR. SE DECISION MADE: 18-FEB-05
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INF 4160, MODEL D-FJ27F
FUJI DYNAMICS LIMITED 510(k) NO: K043407(TRADITIONAL)
ATTN: ANTHONY AH YIN SHUM PHONE NO : 86 769 7728120
LIYATONG INDUSTRIAL DISTRICT SE DECISION MADE: 11-FEB-05
LIN CHUN, TANG XIA 510(k) SUMMARY AVAILABLE FROM FDA
DONG GUAN, GUANGDONG, CHINA
DEVICE: FUKUDA DENSHI MODEL UF-850XTD
FUKUDA DENSHI USA, INC. 510(k) NO: K050363(SPECIAL)
ATTN: LARRY D WALKER PHONE NO : 800-365-6668
17725 N.E. 65TH ST., BLDG. C SE DECISION MADE: 17-FEB-05
REDMOND, WA 98052-4911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CATHETER INTRODUCER
GALT MEDICAL CORP. 510(k) NO: K043525(SPECIAL)
ATTN: DAVID CATLIN PHONE NO : 972-271-5177
2475 MERRITT DR. SE DECISION MADE: 09-FEB-05
GARLAND, TX 75041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-LIGHT
GC AMERICA, INC. 510(k) NO: K050059(TRADITIONAL)
ATTN: TERRY JORITZ PHONE NO : 708-597-0900
3737 WEST 127TH ST. SE DECISION MADE: 03-FEB-05
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: GE LOGIQ TWIN
GENERAL ELECTRIC CO. 510(k) NO: K050126(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
4855 WEST ELECTRIC AVENUE SE DECISION MADE: 02-FEB-05
PO BOX 414 510(k) SUMMARY AVAILABLE FROM FDA
MILWAUKEE, WI 53201
DEVICE: MULTIPLE, MODEL KTJ-50
GOLDEN HORSE MEDICAL EQUIPMENT (WU510(k) NO: K043444(TRADITIONAL)
ATTN: GEORGE SU PHONE NO : 310-229-5748
1800 CENTURY PARK EAST SE DECISION MADE: 22-FEB-05
SUITE 600 510(k) SUMMARY AVAILABLE FROM FDA
LOS ANGELES, CA 90067
DEVICE: ELECTROSURGICAL PENCILS
HANGZHOU SHUYOU MEDICAL INSTRUMENT510(k) NO: K040780(TRADITIONAL)
ATTN: JIAN CHEN, M.D. PHONE NO : 248-366-8869
6868 COLONY DRIVE SE DECISION MADE: 10-FEB-05
WEST BLOOMFIELD, MI 48323 510(k) STATEMENT
DEVICE: MONARCH NASAL IMPLANT
HANSON MEDICAL, INC. 510(k) NO: K041690(TRADITIONAL)
ATTN: GERALD HANSON PHONE NO : 360-297-1997
P.O. BOX 1160 SE DECISION MADE: 11-FEB-05
KINGSTON, WA 98346 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSWORTH BOND
HARRY J. BOSWORTH CO. 510(k) NO: K043170(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE. SE DECISION MADE: 25-FEB-05
SKOKIE, IL 60076 510(k) STATEMENT
DEVICE: HARVARD 2 SYRINGE PUMP, MODEL 2001-001
HARVARD CLINICAL TECHNOLOGY 510(k) NO: K050107(SPECIAL)
ATTN: ERIC J FLACHBART PHONE NO : 508-655-2000
22 PLEASANT ST. SE DECISION MADE: 11-FEB-05
SOUTH NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HL 188 & HL 189 BODY FAT METER
HEALTH & LIFE CO., LTD. 510(k) NO: K043414(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 09-FEB-05
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENTIA
HEARTLAB, INC. 510(k) NO: K050228(SPECIAL)
ATTN: RICHARD PETROCELLI PHONE NO : 401-596-0592
1 CROSSWIND RD. SE DECISION MADE: 18-FEB-05
WESTERLY, RI 02891 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C&G ACUPUNCTURE NEEDLE
HELIO MEDICAL SUPPLIES, INC. 510(k) NO: K043277(TRADITIONAL)
ATTN: ERIC CHENG PHONE NO : 408-433-3355
606 CHARCOT AVE. SE DECISION MADE: 08-FEB-05
SAN JOSE, CA 95131 510(k) STATEMENT
DEVICE: AIRIS ELITE RAPID BODY COIL
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K050307(ABBREVIATED)
ATTN: DOUGLAS THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 28-FEB-05
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOME HEALTH POWER WHEELCHAIR, MODEL HC-200
HOME HEALTH TECHNOLOGY CO., LTD. 510(k) NO: K042719(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 03-FEB-05
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL FACE MASK
HONG YA NON-WOVEN PRODUCTS CO., LT510(k) NO: K043199(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 714-990-6888
590 WEST CENTRAL AVE. SE DECISION MADE: 16-FEB-05
# D 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92821
DEVICE: TRIDENT ACETABULAR SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K033716(TRADITIONAL)
ATTN: DENISE DUCHENE PHONE NO : 201-831-5612
325 CORPORATE DR. SE DECISION MADE: 10-FEB-05
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CE
HOWMEDICA OSTEONICS CORP 510(k) NO: K041940(TRADITIONAL)
ATTN: TERRY SHERIDAN POWELL PHONE NO : 201-831-5493
325 CORPORATE DR. SE DECISION MADE: 11-FEB-05
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCORPIO NRG KNEE SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K042343(TRADITIONAL)
ATTN: DENISE DUCHENE PHONE NO : 201-831-5612
325 CORPORATE DR. SE DECISION MADE: 09-FEB-05
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATI
HOWMEDICA OSTEONICS CORP 510(k) NO: K043374(TRADITIONAL)
ATTN: DENISE DUCHENE PHONE NO : 201-831-5612
325 CORPORATE DR. SE DECISION MADE: 16-FEB-05
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMMA3 NAIL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K043431(TRADITIONAL)
ATTN: JENNIFER KOSOY PHONE NO : 201-831-5601
325 CORPORATE DRIVE SE DECISION MADE: 16-FEB-05
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS
HYDROGEL VISION CORPORATION 510(k) NO: K040303(TRADITIONAL)
ATTN: DONNA HOVANEC PHONE NO : 941-739-1382
6447 PARKLAND DR. SE DECISION MADE: 02-FEB-05
SARASOTA, FL 34243-4035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPIPHYSIS SCREW
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTE510(k) NO: K043410(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952-492-5858
3150 E. 200TH ST. SE DECISION MADE: 24-FEB-05
PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGUS NEXDRIVE, MODEL MI-3000
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K043091(TRADITIONAL)
ATTN: DAVID M LEE PHONE NO : 321-309-8237
2290 W. EAU GALLIE BLVD. SE DECISION MADE: 07-FEB-05
SUITE 210 510(k) STATEMENT
MELBOURNE, FL 32935
DEVICE: MEDICOMPASS CONNECT
IMETRIKUS, INC. 510(k) NO: K042768(TRADITIONAL)
ATTN: DANIEL P OLIVIER PHONE NO : 858-675-8200
16787 BERNARDO CENTER DRIVE SE DECISION MADE: 22-FEB-05
SUITE A-1 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128
DEVICE: INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
INION LTD. 510(k) NO: K043142(TRADITIONAL)
ATTN: HANNA MARTTILA PHONE NO : 358 3 2306600
LAAKARINKATU 2 SE DECISION MADE: 18-FEB-05
TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEURO II-S
INNOVATIVE MAGNETIC RESONANCE IMAG510(k) NO: K050132(TRADITIONAL)
ATTN: THOMAS M TSAKERIS PHONE NO : 301-330-2076
16809 BRIARDALE ROAD SE DECISION MADE: 15-FEB-05
ROCKVILLE, MD 20855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIBERTY SYSTEM
INOVISE MEDICAL, INC. 510(k) NO: K043074(TRADITIONAL)
ATTN: STEVE HESLER PHONE NO : 503-431-3837
10565 SW NIMBUS AVE. SE DECISION MADE: 22-FEB-05
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
PORTLAND, OR 97223
DEVICE: ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D
INSTRUMENTARIUM CORP. IMAGING DIVI510(k) NO: K043612(TRADITIONAL)
ATTN: MARK MASON PHONE NO : 414-747-1030
300 WEST EDGERTON AVE. SE DECISION MADE: 09-FEB-05
MILWAUKEE, WI 53207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL FACTOR XII DEFICIENT PLASMA
INSTRUMENTATION LABORATORY CO. 510(k) NO: K043459(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 09-FEB-05
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SY
INTERACOUSTICS AS 510(k) NO: K043219(TRADITIONAL)
ATTN: DANIEL EGGAN PHONE NO : 952-903-4157
7625 GOLDEN TRIANGLE DRIVE SE DECISION MADE: 04-FEB-05
EDEN PRAIRIE, MN 55344 510(k) STATEMENT
DEVICE: HEMOCHRON SIGNATURE ELITE
INTERNATIONAL TECHNIDYNE CORP. 510(k) NO: K050016(TRADITIONAL)
ATTN: LESLIE YOUNG PHONE NO : 732-548-5700
8 OLSEN AVE. SE DECISION MADE: 10-FEB-05
EDISON, NJ 08820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERGRO DBM
INTERPORE CROSS INTL. 510(k) NO: K031399(TRADITIONAL)
ATTN: MARK LOAR PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 18-FEB-05
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C
INTERVASCULAR 510(k) NO: K042984(TRADITIONAL)
ATTN: AMY AULWES PHONE NO : 781-329-2993
690 CANTON STREET SE DECISION MADE: 18-FEB-05
SUITE 302 510(k) STATEMENT
WESTWOOD, MA 02090
DEVICE: MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
INVATEC INNOVATIVE TECHNOLOGIES, S510(k) NO: K050073(SPECIAL)
ATTN: MIKE WINEGAR PHONE NO : 763-398-7225
4600 NATHAN LANE NORTH SE DECISION MADE: 11-FEB-05
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACELINE EMSAI, MODEL CU580
J. MORITA USA, INC. 510(k) NO: K043496(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070
1425 K ST. N.W. SE DECISION MADE: 16-FEB-05
11TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: TWIN POWER TUEBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE
J. MORITA USA, INC. 510(k) NO: K043498(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070
1425 K ST. N.W. SE DECISION MADE: 16-FEB-05
11TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: SNORENTI
JAMES P BOYD 510(k) NO: K032410(TRADITIONAL)
ATTN: JAMES P BOYD PHONE NO : 858-259-7488
710 MIDORI CT SE DECISION MADE: 28-FEB-05
SOLANA BEACH, CA 92075 510(k) STATEMENT
DEVICE: SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE
LABORATORIOS GRIFOLS, S.A. 510(k) NO: K050339(TRADITIONAL)
ATTN: SEBASTIAN GASCON PHONE NO : 349 357 10100
C/CAN GUASCH, 2 SE DECISION MADE: 25-FEB-05
PARETS DEL VALLES, BARCELONA, SPAI510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PLANET 50 MONITORING SYSTEM
LARSEN & TOUBRO LIMITED 510(k) NO: K043370(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 15-FEB-05
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EASYSPINE SYSTEM
LDR SPINE USA 510(k) NO: K043094(TRADITIONAL)
ATTN: BRIAN BURKINSHAW PHONE NO : 512-437-2582
108 WILD BASIN ROAD SE DECISION MADE: 11-FEB-05
AUSTIN, TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LERADO AVANTICARE POWER WHEELCHAIR, MODEL PW-1800
LERADO OVERSEA LTD. TWN BRANCH (BV510(k) NO: K050087(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 01-FEB-05
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LERADO, COSCO
LERADO OVERSEA LTD. TWN BRANCH (BV510(k) NO: K050290(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 18-FEB-05
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOBEAM NARROW BAND LIGHT THERAPY DEVICES
LIFE WITHOUT PAIN, LLC 510(k) NO: K042813(TRADITIONAL)
ATTN: DANIEL J DILLON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 25-FEB-05
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G
LIFECORE BIOMEDICAL 510(k) NO: K042730(TRADITIONAL)
ATTN: JEREMY HUOTARI PHONE NO : 952-368-6315
3515 LYMAN BLVD. SE DECISION MADE: 14-FEB-05
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALM PATTERNS, VERSION 01.00.00
LMS MEDICAL SYSTEMS LTD. 510(k) NO: K040788(TRADITIONAL)
ATTN: PAMELA J HASWELL PHONE NO : 514 488 3461
5252 DE MAISONNEUVE WEST, #314 SE DECISION MADE: 08-FEB-05
MONTREAL, QC, CANADA H4A 3S5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUPUNCTURE NEEDLES
MARKNEW PRODUCTS 510(k) NO: K043506(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE, SAUSALITO SE DECISION MADE: 11-FEB-05
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: LNOPV AD-L AND PD-L OXIMETRY SENSORS
MASIMO CORPORATION 510(k) NO: K050068(SPECIAL)
ATTN: JAMES CRONIN PHONE NO : 949-297-7218
40 PARKER SE DECISION MADE: 09-FEB-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIPRO SYSTEM
MAYS AND ASSOCIATES, INC. 510(k) NO: K050143(TRADITIONAL)
ATTN: HARVEY KNAUSS PHONE NO : 832-285-9423
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 01-FEB-05
HOUSTON, TX 77071-3404 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEDCOMP SPLIT-CATH II
MEDCOMP 510(k) NO: K040318(TRADITIONAL)
ATTN: JEAN CALLOW PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 03-FEB-05
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K043523(TRADITIONAL)
ATTN: NICOHL WILDING PHONE NO : 800-424-6779
241 W. PALATINE ROAD SE DECISION MADE: 11-FEB-05
WHEELING, IL 60090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8NONE
MEDICAL SOLUTIONS, INC. 510(k) NO: K041839(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888-739-9674
PO BOX 4341 SE DECISION MADE: 15-FEB-05
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM
MEDICON, E.G. 510(k) NO: K043297(SPECIAL)
ATTN: ANGELIKA SCHERP PHONE NO : 312 042 89591
AMSTEL 320-1 SE DECISION MADE: 23-FEB-05
AMSTERDAM, NETHERLANDS 1017AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS
MEDISISS 510(k) NO: K042659(TRADITIONAL)
ATTN: BRANDI JAMES PHONE NO : 541-923-3310
2747 SW 6TH STREET SE DECISION MADE: 14-FEB-05
REDMOND, OR 97756 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS
MEDITECH INTERNATIONAL, INC. 510(k) NO: K041885(TRADITIONAL)
ATTN: RICHARD KEEN PHONE NO : 203-329-2700
1151 HOPE ST. SE DECISION MADE: 24-FEB-05
STAMFORD, CT 06907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS)
MEDOC LTD. ADVANCED MEDICAL SYSTEM510(k) NO: K041908(TRADITIONAL)
ATTN: TRACY GRAY PHONE NO : 763-287-3830
4050 OLSON MEMORIAL HIGHWAY SE DECISION MADE: 25-FEB-05
SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55422
DEVICE: MEDTRONIC CLIP GUN KIT
MEDTRONIC NEUROSURGERY 510(k) NO: K050044(SPECIAL)
ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546
125 CREMONA DR. SE DECISION MADE: 07-FEB-05
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELECT 3D ARTERIAL CANNULA
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K043179(SPECIAL)
ATTN: RONALD W BENNETT PHONE NO : 763-391-9086
7611 NORTHLAND DR. SE DECISION MADE: 08-FEB-05
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRILLIUM BIOPUMP PLUS, MODEL BPX80T
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K050109(SPECIAL)
ATTN: PREETI JAIN PHONE NO : 763-391-9000
7611 NORTHLAND DR. SE DECISION MADE: 11-FEB-05
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS
MEDTRONIC SOFAMOR DANEK 510(k) NO: K031782(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 01-FEB-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K043151(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 01-FEB-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K043321(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 03-FEB-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUADRANT RETRACTOR SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K043602(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 23-FEB-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K050117(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 17-FEB-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K050282(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 18-FEB-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K050079(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 10-FEB-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-Z PEN, REUSEABLE HANDSWITCHING PENCIL
MEGADYNE MEDICAL PRODUCTS, INC. 510(k) NO: K050102(TRADITIONAL)
ATTN: RONDA K MAGNESON PHONE NO : 801-576-9669
11506 SOUTH STATE ST. SE DECISION MADE: 01-FEB-05
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8
MESURE TECHNOLOGY CO.,LTD. 510(k) NO: K050303(SPECIAL)
ATTN: JOHN CHEN PHONE NO : 886 285 122747
7F,86,SEC.1, KWANG FU ROAD SE DECISION MADE: 25-FEB-05
SAN CHUNG CITY, CHINA (TAIWAN) 241510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUCION
MEVISYS CO. LTD 510(k) NO: K050033(TRADITIONAL)
ATTN: RICHARD LANZILLOTTO PHONE NO : 631-744-0059
30 NORTHPORT ROAD SE DECISION MADE: 11-FEB-05
SOUND BEACH, NY 11789-1734 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR
MICROMEDICS, INC. 510(k) NO: K042834(TRADITIONAL)
ATTN: THOMAS A LOPAC PHONE NO : 651-452-1977
1270 EAGAN INDUSTRIAL ROAD SE DECISION MADE: 11-FEB-05
SUITE 120 510(k) STATEMENT
ST PAUL, MN 55121
DEVICE: LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)
MONDEAL MEDICAL SYSTEMS GMBH 510(k) NO: K050257(SPECIAL)
ATTN: ANGELIKA SCHERP PHONE NO : 312 042 89591
AMSTEL 320-1 SE DECISION MADE: 07-FEB-05
AMSTERDAM, NETHERLANDS 1017AP 510(k) STATEMENT
DEVICE: HOLTER RECORDER H3+
MORTARA INSTRUMENT, INC. 510(k) NO: K043010(ABBREVIATED)
ATTN: HARLAN L VAN MATRE PHONE NO : 414-354-1600
7865 NORTH 86TH ST. SE DECISION MADE: 25-FEB-05
MILWAUKEE, WI 53224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HRK-123 KNEE ARRAY COIL
MRI DEVICES CORPORATION 510(k) NO: K050299(SPECIAL)
ATTN: TOM SCHUBERT PHONE NO : 662-524-1402
N27W23676 PAUL RD SE DECISION MADE: 24-FEB-05
PEWAUKEE, WI 53072 510(k) STATEMENT
DEVICE: MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIA
MUELLER WATER CONDITIONING, INC. 510(k) NO: K041884(TRADITIONAL)
ATTN: DAVID W MUELLER PHONE NO : 713-467-3226
1500 SHERWOOD FOREST DR. SE DECISION MADE: 28-FEB-05
HOUSTON, TX 77043-3899 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESS
NEOPROBE CORP. 510(k) NO: K050088(SPECIAL)
ATTN: RODGER A BROWN PHONE NO : 614-822-2342
425 METRO PLACE NORTH, SE DECISION MADE: 08-FEB-05
STE. 300 510(k) SUMMARY AVAILABLE FROM FDA
DUBLIN, OH 43017
DEVICE: COOLTOUCH, MODEL CT3S
NEW STAR LASERS, INC. 510(k) NO: K043046(TRADITIONAL)
ATTN: DONALD V JOHNSON PHONE NO : 916-677-1900
9085 FOOTHILLS BLVD. SE DECISION MADE: 01-FEB-05
ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSMITTER, ZS-940PA SERIES
NIHON KOHDEN AMERICA, INC. 510(k) NO: K043517(ABBREVIATED)
ATTN: SERRAH NAMINI PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 03-FEB-05
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOBELRONDO DENTAL CERAMIC - ZIRCONIA
NOBEL BIOCARE USA, LLC 510(k) NO: K043312(TRADITIONAL)
ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800
22715 SAVI RANCH PARKWAY SE DECISION MADE: 01-FEB-05
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KATANA ZIRCONIA
NORITAKE CO., INC. 510(k) NO: K050160(TRADITIONAL)
ATTN: IVAN J WASSERMAN PHONE NO : 202-342-8400
3050 K STREET, NW, STE 400 SE DECISION MADE: 07-FEB-05
WASHINGTON, DC 20007 510(k) STATEMENT
DEVICE: NUVASIVE COROENT SYSTEM
NUVASIVE, INC. 510(k) NO: K043405(TRADITIONAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-527-1918
4545 TOWNE CENTRE COURT SE DECISION MADE: 07-FEB-05
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
OLSEN MEDICAL 510(k) NO: K042073(TRADITIONAL)
ATTN: TERRY JOHNSON PHONE NO : 650-740-0345
3001 WEST KENTUCKY ST. SE DECISION MADE: 07-FEB-05
LOUISVILLE, KY 40211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K050220(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DR. SE DECISION MADE: 10-FEB-05
MELVILLE, NY 11747-9058 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PSD-60/ENDOPLASMA
OLYMPUS SHIRAKAWA CO., LTD. 510(k) NO: K042274(TRADITIONAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 22-FEB-05
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCE
ONSET MEDICAL CORPORATION 510(k) NO: K043254(TRADITIONAL)
ATTN: ALBERT REGO PHONE NO : 949-770-8710
27001 LA PAZ SUITE 312 SE DECISION MADE: 10-FEB-05
MISSION VIEJO, CA 92691 510(k) STATEMENT
DEVICE: VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND T
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K043384(TRADITIONAL)
ATTN: CAREY A MAYO PHONE NO : 585-453-3482
100 INDIGO CREEK DR. SE DECISION MADE: 07-FEB-05
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TD
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K043386(TRADITIONAL)
ATTN: CAREY A MAYO PHONE NO : 585-453-3482
100 INDIGO CREEK DR. SE DECISION MADE: 07-FEB-05
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM
OSTEOMED L.P. 510(k) NO: K043434(TRADITIONAL)
ATTN: DAWN T HOLDEMAN PHONE NO : 972-677-4600
3885 ARAPAHO RD. SE DECISION MADE: 10-FEB-05
ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXYTEC, MODEL 900
OXYTEC MEDICAL CORPORATION 510(k) NO: K043615(TRADITIONAL)
ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 09-FEB-05
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UPDATED SLIP UROLOGY INTRODUCER SHEATH
PERCUTANEOUS SYSTEMS, INCORPORATED510(k) NO: K042531(SPECIAL)
ATTN: THOMAS LAWSON PHONE NO : 650-969-8800
1300 CRITTENDEN LANE SE DECISION MADE: 01-FEB-05
SUITE 301 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94043
DEVICE: QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121
PHAMATECH INC. 510(k) NO: K043051(TRADITIONAL)
ATTN: CARL MONGIOVI PHONE NO : 858-643-5555
10151 BARNES CANYON RD SE DECISION MADE: 07-FEB-05
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOMENTS MENOPAUSE CHECK, MODEL 9113
PHAMATECH INC. 510(k) NO: K043599(SPECIAL)
ATTN: CARL A MONGIOVI PHONE NO : 858-643-5555
10151 BARNES CANYON RD SE DECISION MADE: 25-FEB-05
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
PHILIPS MEDICAL SYSTEMS 510(k) NO: K050004(SPECIAL)
ATTN: TISHA TREHERNE PHONE NO : 206-664-5283
2301 FIFTH AVE., SUITE 200 SE DECISION MADE: 25-FEB-05
SEATTLE, WA 98121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACHIEVA FAMILY
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K043147(TRADITIONAL)
ATTN: LYNN T HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 15-FEB-05
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003
DEVICE: MULTIDIAGNOST ELEVA
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K050151(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY SE DECISION MADE: 09-FEB-05
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98021-8431 THIRD PARTY REVIEW
DEVICE: THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIV
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K050141(SPECIAL)
ATTN: HAUKE SCHIK PHONE NO : 497 031 6432031
HEWLETT-PACKARD STR.2 SE DECISION MADE: 11-FEB-05
BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIONEER ANTERIOR CERVICAL PLATE SYSTEM
PIONEER SURGICAL TECHNOLOGY 510(k) NO: K043066(TRADITIONAL)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812
375 RIVER PARK CIRCLE SE DECISION MADE: 03-FEB-05
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0
PRACTICEWORKS, INC. 510(k) NO: K043104(TRADITIONAL)
ATTN: DANIEL HOEFER PHONE NO : 770-857-1412
1765 THE EXCHANGE SE DECISION MADE: 24-FEB-05
ATLANTA, GA 30339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPA-SYL
PRODUITS DENTAIRES PIERRE ROLLAND 510(k) NO: K050180(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 11-FEB-05
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM
PROSURG, INC. 510(k) NO: K042780(TRADITIONAL)
ATTN: ASHVIN DESAI PHONE NO : 408-945-4044
2193 TRADE ZONE BLVD. SE DECISION MADE: 03-FEB-05
SAN JOSE, CA 95131 510(k) STATEMENT
DEVICE: ALCOHAWK PRECISION
Q3 INNOVATIONS, LLC 510(k) NO: K043188(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 09-FEB-05
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA
QUANTEL MEDICAL 510(k) NO: K043236(TRADITIONAL)
ATTN: ROGER W BARNES PHONE NO : 501-525-8612
342 SUNSET BAY RD. SE DECISION MADE: 07-FEB-05
HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEALTH FUSION SYSTEM, MODEL RR 1000
R&R MEDICAL, INC. 510(k) NO: K043174(TRADITIONAL)
ATTN: JD WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 07-FEB-05
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX URINE CONTROLS
RANDOX LABORATORIES, LTD. 510(k) NO: K043266(TRADITIONAL)
ATTN: P. ARMSTRONG PHONE NO : 440 289 4422413
55 DIAMOND RD. SE DECISION MADE: 15-FEB-05
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
RANDOX LABORATORIES, LTD. 510(k) NO: K043267(TRADITIONAL)
ATTN: P. ARMSTRONG PHONE NO : 440 289 4422413
55 DIAMOND RD. SE DECISION MADE: 10-FEB-05
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2
RANDOX LABORATORIES, LTD. 510(k) NO: K043268(TRADITIONAL)
ATTN: P ARMSTRONG PHONE NO : 440 289 4422413
55 DIAMOND RD. SE DECISION MADE: 15-FEB-05
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: IPACS PRISM-5.0
REALTIMEIMAGE INC. 510(k) NO: K050298(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 28-FEB-05
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE
REGENERATION TECHNOLOGIES, INC. 510(k) NO: K043420(TRADITIONAL)
ATTN: CARRIE HARTILL PHONE NO : 386-418-8888
11621 RESEARCH CIR. SE DECISION MADE: 10-FEB-05
P.O. BOX 2650 510(k) SUMMARY AVAILABLE FROM FDA
ALACHUA, FL 32616-2650
DEVICE: OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP
REGENERATION TECHNOLOGIES, INC. 510(k) NO: K043421(TRADITIONAL)
ATTN: CARRIE HARTILL PHONE NO : 386-418-8888
11621 RESEARCH CIR. SE DECISION MADE: 16-FEB-05
P.O. BOX 2650 510(k) SUMMARY AVAILABLE FROM FDA
ALACHUA, FL 32616-2650
DEVICE: RESOFIX BIOABSORBABLE EXPANSION BOLT
RESOFIX, INC. 510(k) NO: K043411(TRADITIONAL)
ATTN: CARL KNOBLOCH PHONE NO : 407-977-8609
5349 RED LEAF COURT SE DECISION MADE: 17-FEB-05
OVIEDO, FL 32765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODE
RESPIRONICS, INC. 510(k) NO: K043006(ABBREVIATED)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 11-FEB-05
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VORTEX EZ VASCULAR ACCESS PORT
RITA MEDICAL SYSTEMS, INC. 510(k) NO: K050176(SPECIAL)
ATTN: MARY GOSSARD PHONE NO : 706-846-3126
1 HORIZON WAY SE DECISION MADE: 25-FEB-05
MANCHESTER, GA 31816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONLINE DAT BENZODIAZEPINES PLUS
ROCHE DIAGNOSTICS CORP. 510(k) NO: K043327(TRADITIONAL)
ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE RD. SE DECISION MADE: 07-FEB-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINA-QUANT IGG GEN.2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K050113(TRADITIONAL)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 08-FEB-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES
ROLENCE ENTEPRISE, INC. 510(k) NO: K043325(TRADITIONAL)
ATTN: STERLING CHENG PHONE NO : 886 3 4631999
18-3, LANE 231 SE DECISION MADE: 11-FEB-05
PU-CHUNG ROAD 510(k) STATEMENT
CHUNGI, CHINA (TAIWAN) 320
DEVICE: CERVEX-BRUSH COMBI
ROVERS MEDICAL DEVICES B.V. 510(k) NO: K043369(TRADITIONAL)
ATTN: IR. M.D. ZWART PHONE NO : 31 412 648870
LEKSTRAAT 10 SE DECISION MADE: 02-FEB-05
OSS, NETHERLANDS 5347 KV 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECTRA IDS5 WORKSTATION
SECTRA IMTEC AB 510(k) NO: K050196(SPECIAL)
ATTN: CARL ALLETTO PHONE NO : 214-262-4209
1600 MANCHESTER WAY SE DECISION MADE: 24-FEB-05
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEL MARK V
SENORX, INC. 510(k) NO: K050090(SPECIAL)
ATTN: AMY BOUCLY PHONE NO : 949-362-4800
11 COLUMBIA, SUITE A SE DECISION MADE: 07-FEB-05
ALISO VIEJO, CA 92656 510(k) STATEMENT
DEVICE: SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARI
SHEATHING TECHNOLOGIES, INC. 510(k) NO: K043425(TRADITIONAL)
ATTN: LARRY POLAYES PHONE NO : 408-782-2720
18431 TECHNOLOGY DR. SE DECISION MADE: 28-FEB-05
MORGAN HILL, CA 95037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, L
SHIJAIZHUANG BRILLIANT OCEAN PLAST510(k) NO: K043499(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 909-591-8855
5445 DANIELS STREET SE DECISION MADE: 04-FEB-05
CHINO, CA 91710 510(k) STATEMENT
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED
SHIJIAZHUANG WINFUL PLASTIC CO., L510(k) NO: K043475(TRADITIONAL)
ATTN: CHEN YUHONG PHONE NO : 861 065 666660125
NO. 10B CENTRAL ROAD, AVIC BLD SE DECISION MADE: 01-FEB-05
EAST 3RD RING ROAD 510(k) SUMMARY AVAILABLE FROM FDA
CHAOYANG DISTRICT, BEIJING, CHINA 10002
DEVICE: SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-2
SHIMADZU CORP. 510(k) NO: K043379(ABBREVIATED)
ATTN: RANDAL WALKER PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 17-FEB-05
TORRANCE, CA 90502-1328 510(k) STATEMENT
DEVICE: SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLA
SIEMENS AG 510(k) NO: K043122(TRADITIONAL)
ATTN: GEORGE SCOTT PHONE NO : 303-604-6760
515 COURTNEY WAY SE DECISION MADE: 09-FEB-05
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
LAFAYETTE, CO 80026
DEVICE: SYNGO INSPACE 4D
SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K043469(TRADITIONAL)
ATTN: RUEDIGER KOERNER PHONE NO : 49 919 1189355
SIEMENSSTRASSE 1 SE DECISION MADE: 03-FEB-05
FORCHHEIM, GERMANY 91301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MAGNETOM SYMPHONY A TIM SYSTEM
SIEMENS MEDICAL SOLUTION 510(k) NO: K050199(TRADITIONAL)
ATTN: ANA LADINO PHONE NO : 610-448-4599
51 VALLEY STREAM PKWY. SE DECISION MADE: 18-FEB-05
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K050240(TRADITIONAL)
ATTN: PATRICK LYNCH PHONE NO : 425-557-1825
22010 S.E. 51ST STREET SE DECISION MADE: 15-FEB-05
ISSAQUAH, WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MAGNETOM TRIO A TIM SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K050200(TRADITIONAL)
ATTN: ANA LADINO PHONE NO : 610-448-1785
51 VALLEY STREAM PKWY. SE DECISION MADE: 28-FEB-05
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT
SIGNAL MEDICAL CORP. 510(k) NO: K043289(TRADITIONAL)
ATTN: LOUIS A SERAFIN, JR. PHONE NO : 810-364-7070
400 PYRAMID DR. SE DECISION MADE: 11-FEB-05
MARYSVILLE, MI 48040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RABEA SPINAL IMPLANT
SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K043316(TRADITIONAL)
ATTN: TRACY L GRAY PHONE NO : 763-588-9873
4050 OLSON MEMORIAL HWY SE DECISION MADE: 07-FEB-05
SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55422
DEVICE: SILIMED PECTORAL IMPLANT
SILIMED, INC. 510(k) NO: K042054(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888-729-9674
PO BOX 4341 SE DECISION MADE: 23-FEB-05
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: SMITH & NEPHEW, INC. REVISION KNEE SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K043440(ABBREVIATED)
ATTN: GINO ROUSS PHONE NO : 901-399-6707
1450 E. BROOKS RD. SE DECISION MADE: 18-FEB-05
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASIAN INTRAMEDULLARY HIP SCREW NAILS
SMITH & NEPHEW, INC. 510(k) NO: K050226(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS RD. SE DECISION MADE: 11-FEB-05
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUINOX
SMITHS MEDICAL ASD, INC. 510(k) NO: K050314(TRADITIONAL)
ATTN: DAVID GRAY PHONE NO : 315-363-2330
ONE MADISON ST. SE DECISION MADE: 18-FEB-05
WAMPSVILLE, NY 13163 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES
SOFRADIM PRODUCTION 510(k) NO: K050187(SPECIAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 18-FEB-05
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECURELOC; ADVANCINTRODUCER
SPECIALIZED HEALTH PRODUCTS, INC. 510(k) NO: K050023(TRADITIONAL)
ATTN: MARK NELSON PHONE NO : 801-298-3360
585 WEST 500 SOUTH SE DECISION MADE: 18-FEB-05
BOUNTIFUL, UT 84010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STANSION MATRIX
SPINEWORKS, LLC 510(k) NO: K042600(TRADITIONAL)
ATTN: JONATHAN KAHAN PHONE NO : 202-637-5794
555 13TH STREET N.W. SE DECISION MADE: 18-FEB-05
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT
SSL AMERICAS 510(k) NO: K042957(ABBREVIATED)
ATTN: CHRIS ROBINSON PHONE NO : 770-582-2157
3583 ENGINEERING DR. SUITE 200 SE DECISION MADE: 17-FEB-05
NORCROSS, GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUREX PLAY WARMER LUBRICANT
SSL AMERICAS, INC. 510(k) NO: K042563(TRADITIONAL)
ATTN: CHRIS ROBINSON PHONE NO : 770-582-2222
3585 ENGINEERING DR. SE DECISION MADE: 23-FEB-05
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: THERMAL CAUTERY PROBE
STARION INSTRUMENTS 510(k) NO: K050308(SPECIAL)
ATTN: BRIAN GRIGSBY PHONE NO : 408-741-8773
20665 4TH ST. SE DECISION MADE: 25-FEB-05
SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEALTH PRODUCTS SEATING SYSTEM
STEALTH PRODUCTS 510(k) NO: K050264(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-546-9810
5905 FAWN LANE SE DECISION MADE: 11-FEB-05
CLEVELAND, OH 44141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEREOTAXIS ENDOVASCULAR GUIDE WIRE
STEREOTAXIS, INC. 510(k) NO: K042854(SPECIAL)
ATTN: GARY RAUVOLA PHONE NO : 314-615-6913
4041 FOREST PARK AVE. SE DECISION MADE: 08-FEB-05
ST. LOUIS, MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ENDOVASCULAR GUIDE WIRE
STEREOTAXIS, INC. 510(k) NO: K043457(SPECIAL)
ATTN: GARY RAUVOLA PHONE NO : 314-615-6913
4041 FOREST PARK AVE. SE DECISION MADE: 28-FEB-05
ST. LOUIS, MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONE SOURCE HAC RAPID SETTING CEMENT
STRYKER INSTRUMENTS 510(k) NO: K043334(SPECIAL)
ATTN: WADE T RUTKOSKIE PHONE NO : 269-323-4226
4100 EAST MILHAM AVE. SE DECISION MADE: 09-FEB-05
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER SPINE AVS TL PEEK SPACER
STRYKER SPINE 510(k) NO: K042571(TRADITIONAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 11-FEB-05
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TECHTONIX SYSTEM
STRYKER SPINE 510(k) NO: K050189(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 16-FEB-05
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL
SULTAN CHEMISTS, INC. 510(k) NO: K043054(TRADITIONAL)
ATTN: CLARK SMITH PHONE NO : 201-871-1232
85 WEST FOREST AVE. SE DECISION MADE: 18-FEB-05
ENGLEWOOD, NJ 07631 510(k) STATEMENT
DEVICE: DEVILBISS AUTOADJUST, MODEL 9054 SERIES
SUNRISE MEDICAL 510(k) NO: K043282(TRADITIONAL)
ATTN: STEPHEN KREPELKA PHONE NO : 814-443-7671
100 DEVILBISS DR. SE DECISION MADE: 11-FEB-05
SOMERSET, PA 15501-2125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR
SUNRISE MEDICAL 510(k) NO: K043435(TRADITIONAL)
ATTN: JOSEPH E OLSAVSKY PHONE NO : 814-443-7690
100 DEVILBISS DR. SE DECISION MADE: 11-FEB-05
SOMERSET, PA 15501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGN FIN NAIL
SURGICAL IMPLANT GENERATION NETWOR510(k) NO: K043200(TRADITIONAL)
ATTN: DOUGLAS J DONNELLY PHONE NO : 509-371-1107
2950 GEORGE WASHINGTON WAY SE DECISION MADE: 03-FEB-05
RICHLAND, WA 99352-1615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 3.5MM CORTEX SCREWS
SYNTHES (USA) 510(k) NO: K043185(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 03-FEB-05
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
SYNTHES (USA) 510(k) NO: K050041(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 25-FEB-05
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LARGE BORE SPLITTABLE INTRODUCER KIT
THOMAS MEDICAL PRODUCTS, INC. 510(k) NO: K043438(SPECIAL)
ATTN: TIM STOUDT PHONE NO : 610-296-3000
65 GREAT VALLEY PKWY. SE DECISION MADE: 15-FEB-05
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELLNESS/JOLIVETE
TOHKAI PRECISION IND. LTD. 510(k) NO: K040905(TRADITIONAL)
ATTN: ROBERT T WAGNER PHONE NO : 727-471-0173
2840 SCHERER DRIVE NORTH SE DECISION MADE: 23-FEB-05
SAINT PETERSBURG, FL 33716 510(k) STATEMENT
DEVICE: PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240
TOKYO BOEKI MEDICAL SYSTEM LTD. 510(k) NO: K040958(TRADITIONAL)
ATTN: JAMES M CLINTON PHONE NO : 919-247-0479
5304 GOLDEN MOSS TRAIL SE DECISION MADE: 15-FEB-05
RALEIGH, NC 27613-5662 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K050380(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 23-FEB-05
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON A
TRACOE MEDICAL GMBH 510(k) NO: K043160(TRADITIONAL)
ATTN: MICHAEL A WARREN PHONE NO : 508-898-9300
117 FLANDERS ROAD SE DECISION MADE: 18-FEB-05
WESTBOROUGH, MA 01581 510(k) STATEMENT
DEVICE: 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3
TRIAGE MEDICAL INC 510(k) NO: K043351(TRADITIONAL)
ATTN: GAYLE HIROTA PHONE NO : 949-472-0006
13700 ALTON PKWY. SE DECISION MADE: 18-FEB-05
SUITE 160 510(k) SUMMARY AVAILABLE FROM FDA
IRVINE, CA 92618
DEVICE: MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM
U&I CORP. 510(k) NO: K042928(SPECIAL)
ATTN: BETTY LIM PHONE NO : 82 31 8520102
529-1 YONGHYUN-DONG SE DECISION MADE: 17-FEB-05
EUIJUNGBU, KYUNGGI-DO, REPUBLIC OF510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATALIA TITANIUM SURGICAL MESH
U.S. SPINAL TECHNOLOGIES, LLC. 510(k) NO: K041798(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
PO BOX 560 SE DECISION MADE: 07-FEB-05
STILL WATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERSONAL INJECTOR
UNION MEDICO APS 510(k) NO: K033696(TRADITIONAL)
ATTN: MICHAEL PERTHU PHONE NO : 45 70 266010
EMDRUPVEJ 22 SE DECISION MADE: 16-FEB-05
COPENHAGEN, DENMARK 2100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: USCOM 1A
USCOM, LTD. 510(k) NO: K043139(TRADITIONAL)
ATTN: CHRISTINA KICHULA PHONE NO : 301-998-6151
1700 ROCKVILLE PIKE SE DECISION MADE: 15-FEB-05
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: USGI SHAPELOCK ENDOSCOPIC GUIDE
USGI MEDICAL 510(k) NO: K050253(SPECIAL)
ATTN: MARY LOU MOONEY PHONE NO : 949-369-3890
1140 CALLE CORDILLERA SE DECISION MADE: 28-FEB-05
SAN CLEMENTE, CA 92673 510(k) STATEMENT
DEVICE: VARIAN NASOPHARYNX APPLICATOR
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K042360(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 16-FEB-05
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCON POLARIS GUIDING CATHETER
VASCON LLC 510(k) NO: K043387(TRADITIONAL)
ATTN: STEPHEN F VADAS PHONE NO : 305-477-2406
9344 NW 13TH STREET SE DECISION MADE: 16-FEB-05
MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-STAT RADIAL HEMOSTATIC BAND
VASCULAR SOLUTIONS, INC. 510(k) NO: K050133(SPECIAL)
ATTN: LINDA BUSKLEIN PHONE NO : 763-656-4349
6464 SYCAMORE COURT NORTH SE DECISION MADE: 18-FEB-05
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTEBRON PSS PEDICLE SCREW SYSTEM
VERTEBRON, INC. 510(k) NO: K043152(SPECIAL)
ATTN: LUIS NESPRIDO PHONE NO : 203-380-9340
400 LONG BEACH BLVD. SE DECISION MADE: 01-FEB-05
STRATFORD, CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE
VIDACARE CORPORATION 510(k) NO: K043490(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 18-FEB-05
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITELCARE TURTLE, MODEL 400
VISUAL TELECOMMUNICATIONS NETWORK,510(k) NO: K043368(SPECIAL)
ATTN: ALLEN IZADPANAH PHONE NO : 703-448-0999
8201 GREENSBORO DR., STE. 600 SE DECISION MADE: 01-FEB-05
MCLEAN, VA 22102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER
VIVANT MEDICAL, INC. 510(k) NO: K050223(SPECIAL)
ATTN: KRISTINE FOSS PHONE NO : 650-694-2900
1916-A OLD MIDDLEFIELD WAY SE DECISION MADE: 24-FEB-05
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAVELIGHT SINON
WAVELIGHT LASER TECHNOLOGIE AG 510(k) NO: K050218(TRADITIONAL)
ATTN: MANFRED DRAX PHONE NO : 490 610 23690
FRANKFURTER STRASSE 229 SE DECISION MADE: 15-FEB-05
NEU-ISENBURG, GERMANY D-63263 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BURANE XL
WAVELIGHT LASER TECHNOLOGIE AG 510(k) NO: K050317(TRADITIONAL)
ATTN: ALEXANDER POPP PHONE NO : 49 913 16186121
AM WOLFSMANTEL 5 SE DECISION MADE: 24-FEB-05
ERLANGEN, GERMANY 91058 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: WELL LEAD ENDOTRACHEAL TUBE
WELL LEAD MEDICAL INSTRUMENTS 510(k) NO: K042683(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLERGO LANE SE DECISION MADE: 18-FEB-05
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELL LEAD TRACHEOSTOMY TUBE
WELL LEAD MEDICAL INSTRUMENTS 510(k) NO: K042684(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLERGO LANE SE DECISION MADE: 17-FEB-05
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES
WESTCON CONTACT LENS CO., INC. 510(k) NO: K043540(TRADITIONAL)
ATTN: CAROL NOBLE PHONE NO : 970-245-3845
611 EISENHAUER ST. SE DECISION MADE: 01-FEB-05
GRAND JUNCTION, CO 81505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLUX
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K050203(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 14-FEB-05
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WU'S POWERED WHEELCHAIR, MAMBO 36X
WU'S TECH CO., LTD. 510(k) NO: K050010(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 11-FEB-05
HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WU'S POWERED WHEELCHAIR, MAMBO F 120
WU'S TECH CO., LTD. 510(k) NO: K050011(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 11-FEB-05
HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED
ZIBO ZHUANGYUAN PLASTIC & RUBBER C510(k) NO: K050154(TRADITIONAL)
ATTN: CHEN YUHONG PHONE NO : 861 065 66660
UNIT 707, AVIC BLDG. NO 10B, SE DECISION MADE: 07-FEB-05
CENTRAL RD, E RING RD, 510(k) SUMMARY AVAILABLE FROM FDA
CHAOYANG DISTRICT; BEIJING, CHINA 100022
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
ZIBO ZHUANGYUAN PLASTIC & RUBBER C510(k) NO: K050155(TRADITIONAL)
ATTN: CHEN YUHONG PHONE NO : 861 065 66660
UNIT 707, AVIC BLDG. NO 10B, SE DECISION MADE: 07-FEB-05
CENTRAL RD, E RING RD, 510(k) SUMMARY AVAILABLE FROM FDA
CHAOYANG DISTRICT; BEIJING, CHINA 100022
DEVICE: ZOLL AED PRO EXTERNAL DEFIBRILLATOR
ZOLL MEDICAL CORPORATION 510(k) NO: K041892(TRADITIONAL)
ATTN: SEAN REYNOLDS PHONE NO : 978-421-9386
269 MILL ROAD SE DECISION MADE: 04-FEB-05
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 264
TOTAL WITH SUMMARIES 231
TOTAL WITH STATEMENTS 33
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