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Medical Devices
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November 2004 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-NOV-2004 THROUGH 30-NOV-2004
DEVICE: 3M TEGADERM SILVER
3M COMPANY 510(k) NO: K040890(TRADITIONAL)
ATTN: AMY E SHORT PHONE NO : 651-737-6707
3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 02-NOV-04
ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3VISEON
3MENSIO MEDICAL IMAGING BV 510(k) NO: K043097(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 19-NOV-04
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ETEST FOR GEMIFLOXACIN
AB BIODISK 510(k) NO: K042390(TRADITIONAL)
ATTN: ANNE BOLMSTROM PHONE NO : 46 8 7300760
DALVAGEN 10 SE DECISION MADE: 19-NOV-04
SOLNA, SWEDEN 16956 510(k) STATEMENT
DEVICE: ACCUPACH V
ACCUTOME ULTRASOUND, INC. 510(k) NO: K042752(TRADITIONAL)
ATTN: JEFFREY L WRIGHT PHONE NO : 610-889-0200
263 GREAT VALLEY PARKWAY SE DECISION MADE: 10-NOV-04
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM
ACMI CORPORATION 510(k) NO: K042069(TRADITIONAL)
ATTN: TERRENCE E SULLIVAN PHONE NO : 508-804-2739
136 TURNPIKE RD. SE DECISION MADE: 01-NOV-04
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETSTREAM WORKSPACE
ADAC LABORATORIES 510(k) NO: K042880(TRADITIONAL)
ATTN: COLEEN A COLEMAN PHONE NO : 408-468-3051
540 ALDER DR. SE DECISION MADE: 03-NOV-04
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ADEPT ULTRALITE 532 LASER
ADEPT MEDICAL CONCEPTS, INC. 510(k) NO: K042496(TRADITIONAL)
ATTN: JERRY MCFARLAND PHONE NO : 949-635-9238
29866 AVENIDA DE LAS BANDERAS SE DECISION MADE: 02-NOV-04
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S
AEARO CO. 510(k) NO: K041855(ABBREVIATED)
ATTN: ANN PHILLIPS PHONE NO : 508-764-5713
90 MECHANIC ST. SE DECISION MADE: 10-NOV-04
SOUTHBRIDGE, MA 01550 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INSTANT-VIEW TROPONIN I TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K042227(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DR. SE DECISION MADE: 19-NOV-04
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED DIAMOND BURS
ALLIANCE MEDICAL CORP. 510(k) NO: K041978(TRADITIONAL)
ATTN: ERIC VARTY PHONE NO : 480-763-5335
10232 SOUTH 51ST ST. SE DECISION MADE: 23-NOV-04
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM
ALOKA CO., LTD. 510(k) NO: K043196(TRADITIONAL)
ATTN: RICHARD J CEHOVSKY PHONE NO : 203-269-5088
10 FAIRFIELD BLVD. SE DECISION MADE: 30-NOV-04
WALLINGFORD, CT 06492-7502 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SENSATOUCH
ALUNA MANAGEMENT CO., LTD. 510(k) NO: K042250(TRADITIONAL)
ATTN: CHARITY MARTIN PHONE NO : 877-353-8378
4859 MARTIN CT. SE DECISION MADE: 12-NOV-04
SUITE #5 510(k) SUMMARY AVAILABLE FROM FDA
SMYRNA, GA 30082
DEVICE: AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
AMBU, INC. 510(k) NO: K042682(TRADITIONAL)
ATTN: SANJAY PARIKH PHONE NO : 410-636-1144
611 NORTH HAMMONDS FERRY ROAD SE DECISION MADE: 15-NOV-04
LINTHICUM, MD 21090-1356 510(k) STATEMENT
DEVICE: AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATO
AMBU, INC. 510(k) NO: K042843(TRADITIONAL)
ATTN: SANJAY PARIKH PHONE NO : 410-636-1144
611 NORTH HAMMONDS FERRY ROAD SE DECISION MADE: 12-NOV-04
LINTHICUM, MD 21090-1356 510(k) STATEMENT
DEVICE: 'RAPIDTEC 4' TEST
AMERICAN BIO MEDICA CORP. 510(k) NO: K041712(TRADITIONAL)
ATTN: HENRY WELLS PHONE NO : 410-992-4734
9110 RED BRANCH ROAD SE DECISION MADE: 03-NOV-04
SUITE B 510(k) SUMMARY AVAILABLE FROM FDA
COLUMBIA, MD 21045
DEVICE: MB SYSTEM, BIOENERGY LIGHT THERAPY
AMEST CORP. 510(k) NO: K030275(TRADITIONAL)
ATTN: JOHN IEST PHONE NO : 949-766-9692
30394 ESPERANZA SE DECISION MADE: 29-NOV-04
SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAMOMETER - MODEL FCE AND MODEL MSC
AMETEK 510(k) NO: K042889(TRADITIONAL)
ATTN: PHILIP LACHANCE PHONE NO : 727-536-7831
8600 SOMERSET DR. SE DECISION MADE: 16-NOV-04
LARGO, FL 33773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101
AMPLIFE CORPORATION 510(k) NO: K042906(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 19-NOV-04
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250
ANALOGIC CORP. 510(k) NO: K043025(ABBREVIATED)
ATTN: DONALD J SHERRATT PHONE NO : 978-977-3000
8 CENTENNIAL DR. SE DECISION MADE: 19-NOV-04
CENTENNIAL INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
PEABODY, MA 01960
DEVICE: METRICATH SYSTEM
ANGIOMETRX INC. 510(k) NO: K042685(TRADITIONAL)
ATTN: TIM VERSPAGEN PHONE NO : 604 742 3810
1099 8TH AVENUE WEST SE DECISION MADE: 18-NOV-04
UNIT 107 510(k) SUMMARY AVAILABLE FROM FDA
VANCOUVER, BC, CANADA V6H 1C3
DEVICE: EZY-TRAVEL WRISTBAND
APOTHECARY PRODUCTS, INC. 510(k) NO: K041766(TRADITIONAL)
ATTN: DAVID KRAMER PHONE NO : 952-808-8324
11750 12TH AVE. SOUTH SE DECISION MADE: 26-NOV-04
BURNSVILLE, MN 55337-1295 510(k) STATEMENT
DEVICE: THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS
ARKRAY, INC. 510(k) NO: K041427(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 206-262-7363
510 FURNACE DOCK RD. SE DECISION MADE: 24-NOV-04
CORTLANDT MANOR, NY 10567 510(k) STATEMENT
DEVICE: SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS A
ARKRAY, INC. 510(k) NO: K042443(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 206-262-7363
510 FURNACE DOCK RD. SE DECISION MADE: 24-NOV-04
CORTLANDT MANOR, NY 10567 510(k) STATEMENT
DEVICE: ARTHREX TRIMIT FAMILY
ARTHREX, INC. 510(k) NO: K041189(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 04-NOV-04
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX TENODESIS SCREW FAMILY
ARTHREX, INC. 510(k) NO: K041356(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 04-NOV-04
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCL 30 DERMABLATE ER:YAG LASER SYSTEM
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K042968(SPECIAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DRIVE SE DECISION MADE: 24-NOV-04
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
ATOS MEDICAL AB 510(k) NO: K043138(SPECIAL)
ATTN: EDDY ABERG PHONE NO : 46 415 19800
KRAFTGATAN 8 SE DECISION MADE: 22-NOV-04
HORBY, SWEDEN SE-242 22 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIDI BRAND STERILIZATION WRAP
BANTA HEALTHCARE GROUP, LTD. 510(k) NO: K042580(TRADITIONAL)
ATTN: INA GORDON PHONE NO : 727-797-4727
2454 MCMULLEN BOOTH RD. SE DECISION MADE: 17-NOV-04
CLEARWATER, FL 33759 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM
BARCO NV BARCOVIEW 510(k) NO: K042660(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 19-NOV-04
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM
BARCO NV BARCOVIEW 510(k) NO: K042661(TRADITIONAL)
ATTN: FRANK FURGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 19-NOV-04
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
BARCO NV BARCOVIEW 510(k) NO: K042662(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 22-NOV-04
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: MGP 15 DICOM THEATER
BARCO NV BARCOVIEW 510(k) NO: K042942(TRADITIONAL)
ATTN: FRANK FURGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 22-NOV-04
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: BASBA E-MACHINE
BASBA INC. 510(k) NO: K041172(TRADITIONAL)
ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433
12101 CULLEN BLVD, #A SE DECISION MADE: 18-NOV-04
HOUSTON, TX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PUMP CONNECTIVITY INTERFACE
BAXTER HEALTHCARE CORP. 510(k) NO: K040985(TRADITIONAL)
ATTN: JENNIFER M PAINE PHONE NO : 847-270-5825
ONE BAXTER PKWY. SE DECISION MADE: 30-NOV-04
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE
BAXTER HEALTHCARE CORP. 510(k) NO: K042936(TRADITIONAL)
ATTN: NANETTE HEDDEN PHONE NO : 847-473-6281
ROUTE 120 AND WILSON RD. SE DECISION MADE: 26-NOV-04
ROUND LAKE, IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
BECKMAN COULTER, INC. 510(k) NO: K042291(TRADITIONAL)
ATTN: MARY BETH TANG PHONE NO : 714-961-3777
200 SOUTH KRAEMER BLVD.,W-104 SE DECISION MADE: 12-NOV-04
P.O. BOX 8000 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92822-8000
DEVICE: SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
BECKMAN COULTER, INC. 510(k) NO: K042459(TRADITIONAL)
ATTN: KIM WALKER PHONE NO : 714-961-4912
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 17-NOV-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER
BECTON DICKINSON & CO. 510(k) NO: K042491(TRADITIONAL)
ATTN: LESLIE WOOD PHONE NO : 801-565-2504
9450 SOUTH STATE STREET SE DECISION MADE: 22-NOV-04
SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BBLCHROMAGAR MRSA
BECTON DICKINSON & CO. 510(k) NO: K042812(TRADITIONAL)
ATTN: DENNIS R MERTZ PHONE NO : 410-316-4099
7 LOVETON CIR. SE DECISION MADE: 22-NOV-04
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MUCOTROL CONCENTRATED ORAL GEL WAFER
BELCHER PHARMACEUTICALS, INC. 510(k) NO: K042400(TRADITIONAL)
ATTN: KOTHA SEKHARAM PHONE NO : 727-530-9751
12393 BELCHER ROAD SE DECISION MADE: 24-NOV-04
SUITE 420 510(k) SUMMARY AVAILABLE FROM FDA
LARGO, FL 33773
DEVICE: BEST BREAST BRACHYTHERAPY APPLICATOR
BEST MEDICAL INTERNATIONAL, INC. 510(k) NO: K042586(TRADITIONAL)
ATTN: JOSEPH C WANG PHONE NO : 800-336-4970
7643 FULLERTON RD. SE DECISION MADE: 03-NOV-04
SPRINGFIELD, VA 22153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEST MODEL # 81-01 SERIES IR-192 SOURCES
BEST MEDICAL INTERNATIONAL, INC. 510(k) NO: K042786(ABBREVIATED)
ATTN: JOSEPH C WANG PHONE NO : 800-336-4970
7643 FULLERTON RD. SE DECISION MADE: 18-NOV-04
SPRINGFIELD, VA 22153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BICONITE SURFACE TREATMENT
BICON, INC. 510(k) NO: K031568(TRADITIONAL)
ATTN: VINCENT J MORGAN PHONE NO : 617-390-4363
501 ARBOWAY SE DECISION MADE: 23-NOV-04
BOSTON, MA 02130 510(k) STATEMENT
DEVICE: THE 5.0 X 6.0MM DENTAL IMPLANT
BICON, INC. 510(k) NO: K042637(TRADITIONAL)
ATTN: VINCENT J MORGAN PHONE NO : 617-390-4363
501 ARBOWAY SE DECISION MADE: 15-NOV-04
BOSTON, MA 02130 510(k) STATEMENT
DEVICE: QUEST TUMOR MARKER CONTROL, MODEL 955
BIO-RAD 510(k) NO: K042815(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 05-NOV-04
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK RETICULOCYTE CONTROL (A)
BIO-RAD 510(k) NO: K042836(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 05-NOV-04
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK ELEVATED CRP CONTROL
BIO-RAD 510(k) NO: K042837(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 02-NOV-04
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
BIO-RAD 510(k) NO: K042865(TRADITIONAL)
ATTN: SUZANNE S PARSONS PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 24-NOV-04
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
BIO-RAD LABORATORIES, INC. 510(k) NO: K042446(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO RD. SE DECISION MADE: 02-NOV-04
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES
BIOCOMPATIBLES U.K. LIMITED 510(k) NO: K042231(TRADITIONAL)
ATTN: JOHN GREENBAUM PHONE NO : 954-680-0161
20310 SW 48TH STREET SE DECISION MADE: 12-NOV-04
FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
BIOFILM, INC. 510(k) NO: K041432(TRADITIONAL)
ATTN: ROBERT L DE ARMOND PHONE NO : 760-727-9030
3225 EXECUTIVE RIDGE SE DECISION MADE: 30-NOV-04
VISTA, CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE
BIOGEN 510(k) NO: K042314(TRADITIONAL)
ATTN: VICTOR J GANGI PHONE NO : 617-679-6238
14 CAMBRIDGE CENTER SE DECISION MADE: 22-NOV-04
CAMBRIDGE, MA 02142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENT
BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K041388(TRADITIONAL)
ATTN: GARY BUSSETT PHONE NO : 760-727-5600
2448 CADES WAY SE DECISION MADE: 23-NOV-04
P.O. BOX 1360 510(k) STATEMENT
VISTA, CA 92085-1360
DEVICE: X-SERIES INTEGRAL RPP FEMORAL COMPONENTS
BIOMET, INC. 510(k) NO: K042029(SPECIAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 09-NOV-04
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
BIOMET, INC. 510(k) NO: K042093(TRADITIONAL)
ATTN: TAACY BICKEL JOHNSON PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 01-NOV-04
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818
BIOPRO, INC. 510(k) NO: K041595(TRADITIONAL)
ATTN: DAVID MARK PHONE NO : 810-982-7777
17 SEVENTEENTH ST. SE DECISION MADE: 12-NOV-04
PORT HURON, MI 48060 510(k) STATEMENT
DEVICE: TRIAGE D-DIMER TEST, MODEL 98100
BIOSITE INCORPORATED 510(k) NO: K042890(TRADITIONAL)
ATTN: JEFFERY R DAHLEN PHONE NO : 858-455-4808
11030 ROSELLE ST. SE DECISION MADE: 29-NOV-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VISITOME 20-10 MICROKERATOME
BIOVISION AG 510(k) NO: K042083(TRADITIONAL)
ATTN: DALE SADLIK PHONE NO : 949-450-0770
27 MAUCHLY, UNIT 206 SE DECISION MADE: 16-NOV-04
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSATILE 1 WOUND VACUUM SYSTEM
BLUE SKY MEDICAL GROUP INCORPORATE510(k) NO: K042134(TRADITIONAL)
ATTN: RICHARD WESTON PHONE NO : 760-727-1477
1485 POINSETTIA AVE., STE 118 SE DECISION MADE: 01-NOV-04
VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/
BOSTON SCIENTIFIC CORP. 510(k) NO: K041818(SPECIAL)
ATTN: ROBERT Z PHILLIPS PHONE NO : 510-624-2307
47900 BAYSIDE PARKWAY SE DECISION MADE: 10-NOV-04
FREMONT, CA 94538-6515 510(k) STATEMENT
DEVICE: ENTERYX INJECTION CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K042882(SPECIAL)
ATTN: LISA M QUAGLIA PHONE NO : 508-650-8267
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 09-NOV-04
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER
BUSSE HOSPITAL DISPOSABLES 510(k) NO: K041464(TRADITIONAL)
ATTN: MUHAMAD ANSARI PHONE NO : 631-435-4711
PO BOX 11067 SE DECISION MADE: 05-NOV-04
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIFUSION, MODEL 0609190/0659350
C.R. BARD, INC. 510(k) NO: K041088(ABBREVIATED)
ATTN: LYNN M KIRCHOFF PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 01-NOV-04
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE T
C.R. BARD, INC. 510(k) NO: K042949(TRADITIONAL)
ATTN: JOHN C KNORPP PHONE NO : 770-784-6451
8195 INDUSTRIAL BLVD. SE DECISION MADE: 09-NOV-04
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR
CADWELL LABORATORIES, INC. 510(k) NO: K042350(TRADITIONAL)
ATTN: CHRIS BOLKAN PHONE NO : 509-735-6481
909 NORTH KELLOGG ST. SE DECISION MADE: 03-NOV-04
KENNEWICK, WA 99336 510(k) STATEMENT
DEVICE: CANDELA SMOOTHBEAM LASER SYSTEM
CANDELA CORP. 510(k) NO: K041242(TRADITIONAL)
ATTN: LORRAINE CALZETTA PATROVIC PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 22-NOV-04
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODE
CAO GROUP, INC. 510(k) NO: K041392(TRADITIONAL)
ATTN: ROBERT K LARSEN PHONE NO : 801-256-9282
8683 SOUTH 700 WEST SE DECISION MADE: 08-NOV-04
SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE
CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K042615(TRADITIONAL)
ATTN: ROBERT W JOHNSON PHONE NO : 651-762-2146
1290 HAMMOND RD. SE DECISION MADE: 05-NOV-04
ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMMANDER II
CARDIOCOM 510(k) NO: K043096(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976
6740 RIVERVIEW TERRACE SE DECISION MADE: 24-NOV-04
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: QUADRANT UNIT-1-BOND
CAVEX HOLLAND B.V. 510(k) NO: K042806(TRADITIONAL)
ATTN: RICHARD WOORTMAN PHONE NO : 312 353 07763
HARMENJANSWEG 19-21 SE DECISION MADE: 24-NOV-04
P.O. BOX 852 510(k) STATEMENT
HAARLEM (HOLLAND), NETHERLANDS 2003 RW
DEVICE: NICOM
CHEETAH MEDICAL LTD. 510(k) NO: K042144(TRADITIONAL)
ATTN: BENNY ARAZY PHONE NO : 972 4 9940337
MIZPE AVIV, INDUSTRIAL PARK 13 SE DECISION MADE: 12-NOV-04
M.P. MISGAV, ISRAEL 20187 510(k) STATEMENT
DEVICE: AQUIFY LENS COMFORT DROPS
CIBA VISION CORPORATION 510(k) NO: K042176(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-415-3897
11460 JOHNS CREEK PARKWAY SE DECISION MADE: 03-NOV-04
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400
CLEVELAND MEDICAL DEVICES, INC. 510(k) NO: K042039(TRADITIONAL)
ATTN: ROBERT N SCHMIDT PHONE NO : 216-791-6720
4415 EUCLID AVE SE DECISION MADE: 17-NOV-04
CLEVELAND, OH 44103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE
COAPT SYSTEMS, INC. 510(k) NO: K042796(SPECIAL)
ATTN: BANKIM MEHTA PHONE NO : 650-461-7600
1820 EMBARCADERO RD. SE DECISION MADE: 05-NOV-04
PALO ALTO, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
COBE CARDIOVASCULAR, INC. 510(k) NO: K042473(ABBREVIATED)
ATTN: JACK ELLISON PHONE NO : 303-467-6306
14401 WEST 65TH WAY SE DECISION MADE: 19-NOV-04
ARVADA, CO 80004-3599 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PET-DOSE
COMECER S.R.L. 510(k) NO: K042746(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
PO BOX 4341 SE DECISION MADE: 22-NOV-04
CROFTON, MD 21114 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
COOK, INC. 510(k) NO: K042611(SPECIAL)
ATTN: EARL KNIGHT PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 12-NOV-04
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTAC
COOPERVISION, INC. 510(k) NO: K042824(TRADITIONAL)
ATTN: BONNIE J TSYMBAL PHONE NO : 585-264-3210
711 NORTH RD. SE DECISION MADE: 16-NOV-04
SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY
CORDIS CORP. 510(k) NO: K042969(SPECIAL)
ATTN: DONNA MARSHALL PHONE NO : 908-412-3844
7 POWDER HORN DR. SE DECISION MADE: 08-NOV-04
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHIGENE HEP-ANA TEST SYSTEM
CORGENIX, INC. 510(k) NO: K042680(TRADITIONAL)
ATTN: YUSUKE KOBE PHONE NO : 847-375-9091
455 STATE STREET SE DECISION MADE: 19-NOV-04
DES PLAINES, IL 60016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
CRYOVASCULAR SYSTEMS, INC. 510(k) NO: K042230(TRADITIONAL)
ATTN: KIM TOMPKINS PHONE NO : 408-866-3203
160 KNOWLES DR. SE DECISION MADE: 05-NOV-04
LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL DRAPE KIT - D.I.R.R.A. SRL
D.I.R.R.A. S.R.L. 510(k) NO: K041080(TRADITIONAL)
ATTN: ELISABETTA BACCHI PHONE NO : 39 037 5785829
26, VIA GUIDO ROSSA SE DECISION MADE: 30-NOV-04
(Z.I. GERBOLINA) 510(k) SUMMARY AVAILABLE FROM FDA
VIADANA, MANTOVA, ITALY I - 46019
DEVICE: MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHO
DADE BEHRING, INC. 510(k) NO: K042347(TRADITIONAL)
ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798
BLDG. 500 MAIL BOX 514 SE DECISION MADE: 19-NOV-04
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: ORAJEL ADVANCED TOOTH DESENSITIZER
DEL PHARMACEUTICALS, INC. 510(k) NO: K041680(TRADITIONAL)
ATTN: MARLENE TIETJEN PHONE NO : 516-844-2925
178 EAB PLAZA, PO BX 9357 SE DECISION MADE: 10-NOV-04
UNIONDALE, NY 11553-9357 510(k) STATEMENT
DEVICE: SAVEDENT BLUE
DENFOTEX LIGHT SYSTEMS LTD 510(k) NO: K042196(TRADITIONAL)
ATTN: JOHN COLLES PHONE NO : 441 383 411555
UNIT 15, BELLEKNOWES IND.EST SE DECISION MADE: 01-NOV-04
INVERKEITHING FIFE, SCOTLAND, UNIT510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SOUTH BEACH SMILE LIGHT WHITENING SYSTEM
DENTOVATIONS, INC. 510(k) NO: K042153(TRADITIONAL)
ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433
12101 CULLEN BLVD. SE DECISION MADE: 08-NOV-04
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
HOUSTON, TX 77047
DEVICE: NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
DENTSPLY INTL. 510(k) NO: K042905(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET SE DECISION MADE: 04-NOV-04
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: SPIRALOK ANCHOR
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K041069(TRADITIONAL)
ATTN: KAREN SYLVIA PHONE NO : 781-251-2704
249 VANDERBILT AVE. SE DECISION MADE: 09-NOV-04
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FASTIN RC ANCHOR
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K041075(TRADITIONAL)
ATTN: KAREN SYLVIA PHONE NO : 781-251-2704
249 VANDERBILT DR. SE DECISION MADE: 09-NOV-04
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K042544(TRADITIONAL)
ATTN: SHARON STAROWICZ PHONE NO : 508-828-2867
325 PARAMOUNT DR. SE DECISION MADE: 23-NOV-04
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K041926(TRADITIONAL)
ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396
16 MCCARVILLE ST. SE DECISION MADE: 23-NOV-04
CHARLOTTETOWN, PE, CANADA C1E 2A6 510(k) STATEMENT
DEVICE: LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K041927(TRADITIONAL)
ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396
16 MCCARVILLE ST. SE DECISION MADE: 23-NOV-04
CHARLOTTETOWN, PE, CANADA C1E 2A6 510(k) STATEMENT
DEVICE: HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K041928(TRADITIONAL)
ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396
16 MCCARVILLE ST. SE DECISION MADE: 23-NOV-04
CHARLOTTETOWN, PE, CANADA C1E 2A6 510(k) STATEMENT
DEVICE: PRIMUS US
DRAEGER MEDICAL, INC. 510(k) NO: K042607(TRADITIONAL)
ATTN: JAMES J BRENNAN PHONE NO : 215-721-5400
3135 QUARRY RD. SE DECISION MADE: 26-NOV-04
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE
ED. GEISTLICH SOEHNE AG FUER CHEMI510(k) NO: K042197(TRADITIONAL)
ATTN: PETER S REICHERTZ PHONE NO : 202-408-9222
1301 K STREET NW SE DECISION MADE: 15-NOV-04
SUITE 600 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: REUSABLE FINGER CLIP SPO2 SENSORS
ELEKON INDUSTRIES U.S.A., INC. 510(k) NO: K042704(TRADITIONAL)
ATTN: KRISTA OAKES PHONE NO : 972-849-5167
2300 MCDERMOTT RD. SE DECISION MADE: 26-NOV-04
#200-207 510(k) SUMMARY AVAILABLE FROM FDA
PLANO, TX 75025
DEVICE: METAL/METAL HIP SYSTEM
ENCORE MEDICAL, L.P. 510(k) NO: K040354(SPECIAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 04-NOV-04
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2
ENDO OPTIKS, INC. 510(k) NO: K042918(SPECIAL)
ATTN: KEITH HERTZ PHONE NO : 732-530-6762
39 SYCAMORE AVE. SE DECISION MADE: 22-NOV-04
LITTLE SILVER, NJ 07739-1208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENPATH SAFETY INTRODUCER
ENPATH MEDICAL INCORPORATED 510(k) NO: K041708(TRADITIONAL)
ATTN: KARYL HASKELL PHONE NO : 763-577-2257
15301 HWY. 55 WEST SE DECISION MADE: 30-NOV-04
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGE MEDICAL ACQUISITION STATION (IMAS)
ERAD IMAGEMEDICAL CORP. 510(k) NO: K042700(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648
16303 PANORAMIC WAY SE DECISION MADE: 08-NOV-04
SAN LEANDRO, CA 94578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAMMOTOME MR BIOPSY SYSTEM
ETHICON ENDO-SURGERY, INC. 510(k) NO: K042753(TRADITIONAL)
ATTN: CAROL J SPRINKLE PHONE NO : 513-337-3792
4545 CREEK RD. SE DECISION MADE: 08-NOV-04
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
ETHICON ENDO-SURGERY, INC. 510(k) NO: K042897(TRADITIONAL)
ATTN: ELIZABETH MILLER PHONE NO : 513-337-7146
4545 CREEK RD. SE DECISION MADE: 19-NOV-04
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVATION 12/14 PRESS-FIT FEMORAL STEM
EXACTECH, INC. 510(k) NO: K042842(SPECIAL)
ATTN: LISA SIMPSON PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 09-NOV-04
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELF RETAINING BICANALICULUS INTUBATION SET
FCI OPHTHALMICS, INC. 510(k) NO: K041869(TRADITIONAL)
ATTN: LOUIS ARMAND PHONE NO : 000-000-0000
P.O. BOX 465 SE DECISION MADE: 18-NOV-04
76 PROSPECT ST. 510(k) STATEMENT
MARSHFIELD HILLS, MA 02051
DEVICE: MORTON IUI CATHETERS
FERTILITY TECHNOLOGY RESOURCES, IN510(k) NO: K041470(TRADITIONAL)
ATTN: CONSTANCE W STURGEON PHONE NO : 770-641-9487
4343 SHALLOWFORD RD. SE DECISION MADE: 22-NOV-04
SUITE D-4 510(k) STATEMENT
MARIETTA, GA 30062
DEVICE: ALUMINA HEAD
FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K042035(TRADITIONAL)
ATTN: CHRISTINE QUENDEZ PHONE NO : 33 2 98556895
ZI DE KERNEVEZ-6 RUE NOBEL SE DECISION MADE: 17-NOV-04
QUIMPER, FRANCE 29000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5
FUJINON, INC. 510(k) NO: K041903(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320
543 LONG HILL AVENUE SE DECISION MADE: 10-NOV-04
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5
FUJINON, INC. 510(k) NO: K042043(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320
P.O. BOX 2156 SE DECISION MADE: 24-NOV-04
HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5
FUJINON, INC. 510(k) NO: K042076(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320
P.O. BOX 2156 SE DECISION MADE: 18-NOV-04
HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT CA 125 II ASSAY
FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K042731(TRADITIONAL)
ATTN: KIMBERLY PETERSON PHONE NO : 610-240-3828
201 GREAT VALLEY PKWY. SE DECISION MADE: 19-NOV-04
MALVERN, PA 19355-1307 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A
GAMBRO RENAL PRODUCTS 510(k) NO: K040301(TRADITIONAL)
ATTN: THOMAS B DOWELL PHONE NO : 303-231-4094
10810 WEST COLLINS AVE. SE DECISION MADE: 01-NOV-04
LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRADIA DIRECT LOFLO
GC AMERICA, INC. 510(k) NO: K042348(TRADITIONAL)
ATTN: TERRY JORITZ PHONE NO : 708-597-0900
3737 WEST 127TH ST. SE DECISION MADE: 18-NOV-04
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: AMX5 AND AMX5D MOBILE X-RAY SYSTEMS
GE HEALTHCARE TECHNOLOGIES 510(k) NO: K042866(TRADITIONAL)
ATTN: D. DUERSTELER PHONE NO : 262-312-7029
P.O. BOX 414 SE DECISION MADE: 02-NOV-04
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ADVANCED LUNG ANALYSIS II
GE MEDICAL SYSTEMS 510(k) NO: K042694(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 NORTH GRANDVIEW BLVD. SE DECISION MADE: 18-NOV-04
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRA
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K042642(TRADITIONAL)
ATTN: ANDREW KLUESSENDORF PHONE NO : 414-362-3063
8200 WEST TOWER AVE. SE DECISION MADE: 03-NOV-04
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA
GE MEDICAL SYSTEMS, INC. 510(k) NO: K042844(SPECIAL)
ATTN: LARRY KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 03-NOV-04
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEM-TWIN TENS/ MODELS GM3XY/Z
GEMORE TECHNOLOGY CO., LTD. 510(k) NO: K042559(SPECIAL)
ATTN: BODEN S.P. LAI PHONE NO : 886 288 091799
11 FL, NO. 29-5, SEC. 2 SE DECISION MADE: 17-NOV-04
CHUNG CHENG E. RD. 510(k) SUMMARY AVAILABLE FROM FDA
TAN SHUI, TAIPEI HSIEN, CHINA (TAIWAN) 251
DEVICE: GENEMAX POWER WHEELCHAIR, PW3
GENEMAX MEDICAL PRODUCTS INDUSTRY 510(k) NO: K042748(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5209783
NO. 58, FU-CHIUN ST. SE DECISION MADE: 12-NOV-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENEMAX POWER WHEELCHAIR, PW4
GENEMAX MEDICAL PRODUCTS INDUSTRY 510(k) NO: K042749(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 12-NOV-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM
GENERAL ELECTRIC CO. 510(k) NO: K043112(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 24-NOV-04
W-400 510(k) SUMMARY AVAILABLE FROM FDA
MILWAUKEE, WI 53201
DEVICE: GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTO
GENESIS MEDICAL TECHNOLOGY, INC. 510(k) NO: K041239(TRADITIONAL)
ATTN: THOMAS KROENKE PHONE NO : 303-956-4232
1555 EAST FLAMINGO ROAD SE DECISION MADE: 08-NOV-04
SUITE 155 510(k) SUMMARY AVAILABLE FROM FDA
LAS VEGAS, NV 89119
DEVICE: GENICON SUCTION IRRIGATION SYSTEM
GENICON 510(k) NO: K041967(ABBREVIATED)
ATTN: GARY HABERLAND PHONE NO : 321-297-1189
427 LAKE HOWELL SE DECISION MADE: 12-NOV-04
MAITLAND, FL 32751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENICON BIPOLAR FORCEPS MODEL # 600-005-005
GENICON 510(k) NO: K041968(ABBREVIATED)
ATTN: GARY HABERLAND PHONE NO :
427 LAKE HOWELL SE DECISION MADE: 03-NOV-04
MAITLAND, FL 32751 510(k) STATEMENT
DEVICE: GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO
GIVEN IMAGING LTD. 510(k) NO: K042960(SPECIAL)
ATTN: SHOSH FRIEDMAN PHONE NO : 972 4 9097784
13 HAYETZIRA STREET SE DECISION MADE: 24-NOV-04
NEW INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA
YOKNEAM, ISRAEL 20692
DEVICE: MODIFICATION TO PROTEX STABILIZATION SYSTEM
GLOBUS MEDICAL, INC. 510(k) NO: K042953(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
303 SCHELL LANE SE DECISION MADE: 22-NOV-04
PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
GRAND WORK PLASTIC PRODUCTS CO., L510(k) NO: K042830(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 714-990-6488
590 W. CENTRAL AVE., #D SE DECISION MADE: 17-NOV-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS
GUANGZHOU FORTUNIQUE LTD. 510(k) NO: K041501(TRADITIONAL)
ATTN: JANE B CAMPBELL PHONE NO : 845-469-4289
485 LAROE ROAD SE DECISION MADE: 30-NOV-04
CHESTER, NY 10918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM
GUIDANT CORP. 510(k) NO: K042908(SPECIAL)
ATTN: VIRGINIA SINGER PHONE NO : 408-845-2233
3200 LAKESIDE DR. SE DECISION MADE: 12-NOV-04
SANTA CLARA, CA 95054-2807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERICHEK GLUTARALDEHYDE REAGENT STRIPS
HACH COMPANY 510(k) NO: K040660(TRADITIONAL)
ATTN: DAVID A MORRIS PHONE NO : 219-262-2060
23575 COUNTY ROAD 106 SE DECISION MADE: 15-NOV-04
ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL
HEALTH & LIFE CO., LTD. 510(k) NO: K042853(SPECIAL)
ATTN: PAUL HUNG PHONE NO : 886 2 82271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 10-NOV-04
CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT
DEVICE: HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SO
HOSPIRA, INC. 510(k) NO: K042980(SPECIAL)
ATTN: PATRICIA MELERSKI PHONE NO : 224-212-4880
275 N. FIELD DR., BLDG. H-2 SE DECISION MADE: 17-NOV-04
D-389 510(k) SUMMARY AVAILABLE FROM FDA
LAKE FOREST, IL 60045-5045
DEVICE: SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT
HOWMEDICA OSTEONICS CORP 510(k) NO: K042883(SPECIAL)
ATTN: DENISE DUCHENE PHONE NO : 201-831-5612
325 CORPORATE DR. SE DECISION MADE: 23-NOV-04
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K041170(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
325 CORPORATE DRIVE SE DECISION MADE: 09-NOV-04
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IOP8 INTRA OPERATIVE PROBE
HUNTLEIGH HEALTHCARE, INC. 510(k) NO: K032315(TRADITIONAL)
ATTN: B.J. COLLEYPRIEST PHONE NO : 800-223-1218
35 PORTMANMOOR ROAD SE DECISION MADE: 18-NOV-04
CARDIFF, UNITED KINGDOM CF24 5HN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILLENIUM, MODELS 2000, 2001 AND 2002
HYPERBARIC FOR LIFE LLC 510(k) NO: K041007(TRADITIONAL)
ATTN: RICK RYDER PHONE NO : 602-973-1776
3206 WEST STATE AVE. SE DECISION MADE: 15-NOV-04
PHOENIX, AZ 85051 510(k) STATEMENT
DEVICE: SECOND LOOK VIEWER
ICAD INC. 510(k) NO: K042697(TRADITIONAL)
ATTN: JOHN ROSENSTENGEL PHONE NO : 937-431-7978
2689 COMMONS BLVD., SUITE 100 SE DECISION MADE: 19-NOV-04
BEAVERCREEK, OH 45431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMALUX NIRIS IMAGING SYSTEM
IMALUX CORPORATION 510(k) NO: K042894(SPECIAL)
ATTN: STEPHANIE HARRINGTON PHONE NO : 216-502-0755
1771 EAST 30TH STREET SE DECISION MADE: 19-NOV-04
CLEVELAND, OH 44114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WEST NILE DETECT IGM ELISA
INBIOS INTL., INC. 510(k) NO: K041817(TRADITIONAL)
ATTN: ESTELA I RAYCHAUDHURI PHONE NO : 206-344-5821
562 1ST. AVE. SOUTH, SUITE 600 SE DECISION MADE: 19-NOV-04
SEATTLE, WA 98104 510(k) STATEMENT
DEVICE: INNOJECT AUTO-INJECTOR
INNOJECT, INC 510(k) NO: K042557(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5600
555 THIRTEENTH STREET, NW SE DECISION MADE: 08-NOV-04
WASHINGTON, DC 20004-5600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM
INTERPORE CROSS INTL. 510(k) NO: K042798(SPECIAL)
ATTN: WENDY SPIELBERGER PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 04-NOV-04
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT
INTUITIVE SURGICAL, INC. 510(k) NO: K042855(SPECIAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100
950 KIFER RD. SE DECISION MADE: 12-NOV-04
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHE
INVATEC INNOVATIVE TECHNOLOGIES 510(k) NO: K042537(TRADITIONAL)
ATTN: MIKE WINEGAR PHONE NO : 763-398-7225
4600 NATHAN LANE NORTH SE DECISION MADE: 08-NOV-04
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
INVATEC INNOVATIVE TECHNOLOGIES 510(k) NO: K042538(TRADITIONAL)
ATTN: MIKE WINEGAR PHONE NO : 763-398-7225
4600 NATHAN LANE NORTH SE DECISION MADE: 08-NOV-04
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE E
IRVINE BIOMEDICAL, INC. 510(k) NO: K042775(SPECIAL)
ATTN: BONNIE BISHOP PHONE NO : 949-851-3053
2375 MORSE AVE. SE DECISION MADE: 04-NOV-04
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TETRIC EVOCERAM
IVOCLAR VIVADENT, INC. 510(k) NO: K042819(TRADITIONAL)
ATTN: DONNA HARTNETT PHONE NO : 716-691-2260
175 PINEVIEW DR. SE DECISION MADE: 09-NOV-04
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: FRC POSTEC PLUS
IVOCLAR VIVADENT, INC. 510(k) NO: K042848(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 22-NOV-04
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: K.E.P. CONNECTOR AND CLIP
K.E.P., LLC 510(k) NO: K042900(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 05-NOV-04
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KASIOS TCP
KASIOS BIOMATERIALS 510(k) NO: K042340(TRADITIONAL)
ATTN: LAETITA BERNARD PHONE NO : 909-699-6262
45900 PARSIPPANY COURT SE DECISION MADE: 24-NOV-04
TEMECULA, CA 92592 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RONDOFLEX PLUS 360
KAVO AMERICA CORPORATION 510(k) NO: K042872(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 23-NOV-04
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KENDALL CO2NFIRM NOW CO2 DETECTOR
KENDALL 510(k) NO: K042572(TRADITIONAL)
ATTN: BRIDGET GARDNER PHONE NO : 508-261-8532
15 HAMPSHIRE ST. SE DECISION MADE: 05-NOV-04
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEMETRON IDS CURING LIGHT
KERR CORP. 510(k) NO: K042888(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVE. SE DECISION MADE: 10-NOV-04
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRY LASER IMAGER, MODEL DRYPRO MODEL 793
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K042133(TRADITIONAL)
ATTN: SHINICHI YAMANAKA PHONE NO : 815 963 70190
PROGRESS SECTION SE DECISION MADE: 24-NOV-04
319 AKENO, OBATA-CHO 510(k) SUMMARY AVAILABLE FROM FDA
WATARAI-GUN; MIE-KEN, JAPAN 519-05
DEVICE: CLEARFIL TRI-S BOND
KURARAY MEDICAL INC. 510(k) NO: K042913(TRADITIONAL)
ATTN: SATOSHI YAMAGUCHI PHONE NO : 212-986-2230
101 EAST 52ND STREET, 26TH FL. SE DECISION MADE: 26-NOV-04
NEW YORK, NY 10022 510(k) STATEMENT
DEVICE: LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (
LAGLOVE (M) SDN. BHD. 510(k) NO: K042618(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 873 35411
LOT 478, JALAN SIMPANG BALAK, SE DECISION MADE: 26-NOV-04
OFF BATU 13, JALAN CHERAS 510(k) STATEMENT
KAJANG, SELANGOR, DARUL EHSAN, MALAYSIA 43000
DEVICE: IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE)
LIFEPOINT,INC 510(k) NO: K041746(TRADITIONAL)
ATTN: DAVID B GOLDBERG, PH.D. PHONE NO : 909-418-3048
1205 SOUTH DUPONT ST. SE DECISION MADE: 23-NOV-04
ONTARIO, CA 91761 510(k) STATEMENT
DEVICE: IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE)
LIFEPOINT,INC 510(k) NO: K041747(TRADITIONAL)
ATTN: DAVID B GOLDBERG PHONE NO : 909-418-3048
1205 SOUTH DUPONT ST. SE DECISION MADE: 24-NOV-04
ONTARIO, CA 91761 510(k) STATEMENT
DEVICE: DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCH
LINVATEC BIOMATERIALS, LTD. 510(k) NO: K042966(SPECIAL)
ATTN: TUIJA ANNALA PHONE NO : 358 3 3165679
HERMIANKATU 6-8L SE DECISION MADE: 19-NOV-04
TAMPERE, FINLAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULIN
LINVATEC CORP. 510(k) NO: K042778(SPECIAL)
ATTN: ELIZABETH PAUL PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 04-NOV-04
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIV ANTAGE DH POWER INJECTION SYSTEM
MALLINCKRODT INC., LIEBEL-FLARSHEI510(k) NO: K042744(SPECIAL)
ATTN: ELLIS ROGERS PHONE NO : 513-948-4041
2111 EAST GALBRAITH RD. SE DECISION MADE: 30-NOV-04
CINCINNATI, OH 45237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEELINE MOTIV, PROPOLIS, PCA
MCKINLEY, INC. 510(k) NO: K042228(TRADITIONAL)
ATTN: MICHELLE PRATTE PHONE NO : 303-420-9569
4080 YOUNGFIELD ST. SE DECISION MADE: 08-NOV-04
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LE
MED-GENERAL TECHNOLOGIES LLC 510(k) NO: K042382(TRADITIONAL)
ATTN: PAUL MCCREIGHT PHONE NO : 239-566-8865
1016 COLLIER CENTER WAY SE DECISION MADE: 30-NOV-04
SUITE 102 510(k) STATEMENT
NAPLES, FL 34110
DEVICE: 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER
MEDCOMP 510(k) NO: K040328(TRADITIONAL)
ATTN: ROSANNA SEVERINI PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 24-NOV-04
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICULT IVM SYSTEM
MEDI-CULT A/S 510(k) NO: K041284(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751
9915 CAM. CHIRIMOLLA SE DECISION MADE: 22-NOV-04
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
MEDICAL ACTION INDUSTRIES, INC. 510(k) NO: K042527(TRADITIONAL)
ATTN: ROBIN BLANKENBAKER PHONE NO : 828-681-8820
25 HEYWOOD RD. SE DECISION MADE: 08-NOV-04
ARDEN, NC 28704 510(k) STATEMENT
DEVICE: MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K042717(TRADITIONAL)
ATTN: MARY THORSNESS PHONE NO : 805-987-7891
5300 ADOLFO RD. SE DECISION MADE: 05-NOV-04
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (S
MEDICAL DESIGNS, LLC 510(k) NO: K042359(TRADITIONAL)
ATTN: PAUL JOHN AXT PHONE NO : 605-376-6008
1210 W. 18TH ST. SE DECISION MADE: 17-NOV-04
NORTH CENTER, SUITE 104 510(k) SUMMARY AVAILABLE FROM FDA
SIOUX FALLS, SD 57104
DEVICE: ATRILAZE SOFT TISSUE ABLATION SYSTEM
MEDICALCV, INC. 510(k) NO: K040744(TRADITIONAL)
ATTN: DENNY STEGER PHONE NO : 651-452-3000
9725 SOUTH ROBERT TRAIL SE DECISION MADE: 30-NOV-04
INVER GROVE HEIGHTS, MN 55077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRADE PRODICT'S SOOTHING GEL PATCH
MEDTRADE PRODUCTS LTD. 510(k) NO: K030901(TRADITIONAL)
ATTN: JONATHAN RANFIELD PHONE NO : 44 127 0500019
ELECTRA HOUSE SE DECISION MADE: 26-NOV-04
CREWE BUSINESS PARK CREWE 510(k) STATEMENT
CHESHIRE, UNITED KINGDOM CW1 6GL
DEVICE: MSD SILO SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K042210(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 04-NOV-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K042790(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 04-NOV-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K042886(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 18-NOV-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTURE ANTERIOR CERVICAL PLATING SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K042922(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 19-NOV-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOBRA GPS FIXATION SYSTEM
MEDTRONIC VERTELINK, INC. 510(k) NO: K042859(TRADITIONAL)
ATTN: ALBERT REGO PHONE NO : 949-770-8710
27001 LA PAZ, SUITE 312 SE DECISION MADE: 24-NOV-04
MISSION VIEJO, CA 92691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT
MENTOR CORP. 510(k) NO: K042851(SPECIAL)
ATTN: DONNA CRAWFORD PHONE NO : 805-879-6304
201 MENTOR DRIVE SE DECISION MADE: 09-NOV-04
SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADSEAL ROOT CANAL SEALER
META BIOMED CO., LTD. 510(k) NO: K042769(TRADITIONAL)
ATTN: JENNY SHON PHONE NO : 718-639-7460
41-19, 77TH STREET SE DECISION MADE: 24-NOV-04
ELMHURST, NY 11373 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100
MICRO-MEGA SOCIETE ANONYME 510(k) NO: K042171(TRADITIONAL)
ATTN: PHILIPPE GARCIA PHONE NO : 333 815 44231
5-12 RUE DU TUNNEL SE DECISION MADE: 10-NOV-04
CEDEX BESANCON, FRANCE 25006 510(k) STATEMENT
DEVICE: MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002
MINRAD, INC. 510(k) NO: K041852(TRADITIONAL)
ATTN: JOHN MCNEIRNEY PHONE NO : 716-855-1068
847 MAIN ST. SE DECISION MADE: 15-NOV-04
BUFFALO, NY 14203 510(k) STATEMENT
DEVICE: SMOKE EVACUATION ATTACHEMENT
MODERN MEDICAL EQUIPMENT MFG., LTD510(k) NO: K033095(TRADITIONAL)
ATTN: DAVID LOU PHONE NO : 852 242 09068
5/F GOLD KING IND. BLDG. 35 SE DECISION MADE: 17-NOV-04
TAI LIN PAI ROAD 510(k) STATEMENT
KWAI CHUNG N.T., HONG KONG
DEVICE: MINIMESH POLYPROPYLENE MESH
MPATHY MEDICAL DEVICES, LTD. 510(k) NO: K041632(TRADITIONAL)
ATTN: LOUIS J MAZZARESE PHONE NO : 203-254-3565
150 ARAN HILL ROAD SE DECISION MADE: 17-NOV-04
FAIRFIELD, CT 06824-1712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLA
NATIONAL DISPLAY SYSTEMS 510(k) NO: K042353(TRADITIONAL)
ATTN: RON HANSEN PHONE NO : 408-776-0085
16245 VINEYARD BLVD. SE DECISION MADE: 24-NOV-04
MORGAN HILL, CA 95037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOPLANT IMPLANT SYSTEM
NEOBIOTECH CO., LTD. 510(k) NO: K042339(TRADITIONAL)
ATTN: DAE KYU CHANG PHONE NO : 562-404-8466
13340E FIRESTONE BLVD. STE. J SE DECISION MADE: 02-NOV-04
SANTE FE SPRINGS, CA 90670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA
NEW STAR LASERS, INC. 510(k) NO: K041323(TRADITIONAL)
ATTN: DONALD V JOHNSON PHONE NO : 916-677-1912
9085 FOOTHILLS BLVD. SE DECISION MADE: 17-NOV-04
ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXUS INTRAVENOUS TUBING SETS ("NIVTS")
NEXUS MEDICAL, LLC 510(k) NO: K041861(TRADITIONAL)
ATTN: AL BOEDEKER PHONE NO : 913-451-2234
11315 STRANG LINE ROAD SE DECISION MADE: 26-NOV-04
LENEXA, KS 66215 510(k) STATEMENT
DEVICE: PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-105
NOBEL BIOCARE AB 510(k) NO: K043042(TRADITIONAL)
ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 18-NOV-04
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55
NOUVAG AG 510(k) NO: K042434(TRADITIONAL)
ATTN: ERICH FORSTER PHONE NO : 41 56 2019500
REUSSWEHRSTRASSE 1 SE DECISION MADE: 03-NOV-04
GEBENSTORF, SWITZERLAND 5412 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NX STAGE WATER PURIFICATION SYSTEM
NX STAGE MEDICAL INC 510(k) NO: K042089(TRADITIONAL)
ATTN: NORMA LEMAY PHONE NO : 978-687-4700
439 SOUTH UNION ST. STE 501 SE DECISION MADE: 24-NOV-04
LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906
OMRON HEALTHCARE, INC. 510(k) NO: K043018(SPECIAL)
ATTN: LARRY LEPLEY PHONE NO : 847-247-5733
1200 LAKESIDE DRIVE SE DECISION MADE: 10-NOV-04
BANNOCKBURN, IL 60015 510(k) STATEMENT
DEVICE: OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016
OPTICON MEDICAL 510(k) NO: K041983(TRADITIONAL)
ATTN: GLENN D BRUNNER PHONE NO : 614-336-2000
7001 POST RD., SUITE 100 SE DECISION MADE: 17-NOV-04
DUBLIN, OH 43016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE
OPUS MEDICAL, INC. 510(k) NO: K042914(SPECIAL)
ATTN: LAURA N KASPEROWICZ PHONE NO : 949-234-0400
27127 CALLE ARROYO, SUITE 1924 SE DECISION MADE: 12-NOV-04
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUFFPATCH
ORGANOGENESIS, INC. 510(k) NO: K042809(TRADITIONAL)
ATTN: PATRICK R BILBO PHONE NO : 781-401-1110
150 DAN RD. SE DECISION MADE: 02-NOV-04
CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART BITEBLOC
ORIDION MEDICAL 1987 LTD. 510(k) NO: K042665(TRADITIONAL)
ATTN: SANDY BROWN PHONE NO : 972 258 99115
7 HAMARPE ST. P.O. BOX 45025 SE DECISION MADE: 23-NOV-04
HAR HOTZVIM INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
JERUSALEM, ISRAEL 91450
DEVICE: QUIKREAD CRP CALIBRATOR SET
ORION DIAGNOSTICA OY 510(k) NO: K042625(TRADITIONAL)
ATTN: ANNIKHA RANTAMA PHONE NO : 358 104 292736
KOIVU MANKKAAN TIE 6 SE DECISION MADE: 18-NOV-04
ESPOO, FINLAND 02200 510(k) STATEMENT
DEVICE: VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEM
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K042475(TRADITIONAL)
ATTN: MARLENE HANNA PHONE NO : 585-453-3000
100 INDIGO CREEK DR. SE DECISION MADE: 10-NOV-04
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUC
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K042477(TRADITIONAL)
ATTN: DARLENE J PHILLIPS PHONE NO : 585-453-4253
100 INDIGO CREEK DR. SE DECISION MADE: 19-NOV-04
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K042520(TRADITIONAL)
ATTN: CAREY A MAYO PHONE NO : 585-453-3482
100 INDIGO CREEK DR. SE DECISION MADE: 30-NOV-04
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KI
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K042521(TRADITIONAL)
ATTN: MARLENE A HANNA PHONE NO : 585-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 18-NOV-04
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB P
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K042643(TRADITIONAL)
ATTN: DARLENE J PHILLIPS PHONE NO : 585-453-4253
100 INDIGO CREEK DR. SE DECISION MADE: 18-NOV-04
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAUMACAD 1.2
ORTHOCRAT, LTD. 510(k) NO: K042816(TRADITIONAL)
ATTN: ADI ICKOWICZ PHONE NO : 972 392 33666
34/3 BAR KOHVA ST. SE DECISION MADE: 10-NOV-04
TEL AVIV, ISRAEL 63427 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ORTHOFIX VOLAR DISTAL RADIAL PLATE
ORTHOFIX, INC. 510(k) NO: K042766(TRADITIONAL)
ATTN: NICOLLE L FERRIS PHONE NO : 469-742-2578
1720 BRAY CENTRAL DR. SE DECISION MADE: 16-NOV-04
MCKINNEY, TX 75069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K041443(SPECIAL)
ATTN: SAM SON PHONE NO : 410-785-0700
11201 PEPPER RD. SE DECISION MADE: 16-NOV-04
HUNT VALLEY, MD 21031-1201 510(k) STATEMENT
DEVICE: PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP
PACK & PROPER CO., LTD. 510(k) NO: K042653(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58 FU-CHIUN ST. SE DECISION MADE: 26-NOV-04
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT
DEVICE: VAG O SPECULUM, MODELS VS1, VM1, VL1
PANATREX, INC. 510(k) NO: K042950(TRADITIONAL)
ATTN: KEVIN KUO PHONE NO : 714-630-5582
1648 SIERRA MADRE CIR. SE DECISION MADE: 30-NOV-04
PLACENTIA, CA 92870-6626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROGEL CANALICULAR PLUG
PARTNERS IN BIOMATERIALS, INC. 510(k) NO: K040912(TRADITIONAL)
ATTN: JAMES CHRISTENSEN PHONE NO : 909-305-5400
466 WEST ARROW HWY., UNIT H SE DECISION MADE: 16-NOV-04
SAN DIMAS, CA 91773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROVERTER URETERAL ACCESS SHEATH
PERCUTANEOUS SYSTEMS, INC. 510(k) NO: K042877(TRADITIONAL)
ATTN: THOMAS LAWSON PHONE NO : 650-969-8800
1300 CRITTENDEN LANE # 301 SE DECISION MADE: 16-NOV-04
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS ORTHOPAEDIC APPLICATIONS
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K042867(TRADITIONAL)
ATTN: LYNN T HARMER PHONE NO : 425-478-7312
22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 02-NOV-04
BOTHELL, WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GEMINI GXL
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K042935(TRADITIONAL)
ATTN: RAE ANN FARROW PHONE NO : 440-483-2647
595 MINER RD. SE DECISION MADE: 09-NOV-04
CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLI
PHILIPS MEDIZINSYSTEME BOBLINGEN G510(k) NO: K042845(SPECIAL)
ATTN: EGON PFEIL PHONE NO : 497 031 4631925
HEWLETT PACKARD STR. 2 SE DECISION MADE: 12-NOV-04
BOBINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PMD-2000 INTERFERENTIAL STIMULATOR
PHOENIX MEDICAL DEVICES, LLC 510(k) NO: K042881(TRADITIONAL)
ATTN: JIM KLETT PHONE NO : 949-515-4492
620 NEWPORT CENTER SE DECISION MADE: 18-NOV-04
SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA
NEWPORT BEACH, CA 92660 THIRD PARTY REVIEW
DEVICE: PLANMED SOPHIE NUANCE CLASSIC
PLANMED OY 510(k) NO: K042671(TRADITIONAL)
ATTN: BOB PIENKOWSKI PHONE NO : 630-894-2200
100 NORTH GRAY AVE. SUITE A SE DECISION MADE: 19-NOV-04
ROSELLE, IL 60172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWCARE SYSTEM
POINTCARE TECHNOLOGIES INC. 510(k) NO: K041882(TRADITIONAL)
ATTN: CYNTHIA A SINCLAIR PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 23-NOV-04
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVOSORB SHEET, MODEL FS01
POLYGANICS BV 510(k) NO: K042811(TRADITIONAL)
ATTN: JAN NIEUWENHUIS PHONE NO : 315 058 86588
L.J. ZIELSTRAWEG 1 SE DECISION MADE: 08-NOV-04
GRONINGEN, NETHERLANDS 9713-GX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)
POSSIS MEDICAL, INC. 510(k) NO: K042874(SPECIAL)
ATTN: MARK STENOIEN PHONE NO : 763-780-4555
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 05-NOV-04
MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATUS FIRST STREP A
PRINCETON BIOMEDITECH CORP. 510(k) NO: K040708(TRADITIONAL)
ATTN: JEMO KANG PHONE NO : 732-274-1000
4242 U.S. RT. 1 SE DECISION MADE: 22-NOV-04
MONMOUTH JUNCTION, NJ 08852-1905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WAT
QINGDAO BESTEX RUBBER & PLASTIC PR510(k) NO: K042645(TRADITIONAL)
ATTN: ZECHUAN SHAO PHONE NO : 408-980-1348
2576 LAFAYETTE ST. SE DECISION MADE: 26-NOV-04
SANTA CLARA, CA 95050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIBROTEK FIB
R2 DIAGNOSTICS, INC. 510(k) NO: K042919(TRADITIONAL)
ATTN: PEGGY S CARTER PHONE NO : 574-288-4377
412 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 29-NOV-04
SOUTH BEND, IN 46601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX CANNABINOIDS ASSSAY
RANDOX LABORATORIES, LTD. 510(k) NO: K041142(TRADITIONAL)
ATTN: P. ARMSTRONG PHONE NO : 440 289 4422413
55 DIAMOND RD. SE DECISION MADE: 23-NOV-04
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX BARBITURATE ASSAY
RANDOX LABORATORIES, LTD. 510(k) NO: K041143(TRADITIONAL)
ATTN: P. ARMSTRONG PHONE NO : 440 289 4422413
55 DIAMOND RD. SE DECISION MADE: 05-NOV-04
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: RANDOX OPIATES ASSAY
RANDOX LABORATORIES, LTD. 510(k) NO: K041144(TRADITIONAL)
ATTN: P. ARMSTRONG PHONE NO : 440 289 4422413
55 DIAMOND RD. SE DECISION MADE: 03-NOV-04
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
REMEL INC 510(k) NO: K041951(TRADITIONAL)
ATTN: MARY ANN SILVIUS PHONE NO : 913-895-4054
12076 SANTA FE DRIVE SE DECISION MADE: 15-NOV-04
LENEXA, KS 66215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESTITU
RESONANT MEDICAL, INC. 510(k) NO: K041937(TRADITIONAL)
ATTN: SEAN M CURRY PHONE NO : 858-675-8200
16787 BERNARDO CENTER DRIVE SE DECISION MADE: 16-NOV-04
SUITE A-1 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128
DEVICE: CAPNOSTAT 5
RESPIRONICS NOVAMETRIX, INC. 510(k) NO: K042601(SPECIAL)
ATTN: KEVIN MADER PHONE NO : 203-697-6466
5 TECHNOLOGY DR. SE DECISION MADE: 19-NOV-04
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
ROCHE DIAGNOSTICS CORP. 510(k) NO: K043095(SPECIAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544
9115 HAGUE RD. SE DECISION MADE: 23-NOV-04
P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
ROCHE DIAGNOSTICS CORP. 510(k) NO: K043175(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544
9115 HAGUE RD. SE DECISION MADE: 24-NOV-04
PO BX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: GUIDEWIRES
ROCKET MEDICAL PLC 510(k) NO: K042264(TRADITIONAL)
ATTN: T. CHARLTON PHONE NO : 00 44 1914194488
WEAR INDUSTRIAL ESTATE SE DECISION MADE: 24-NOV-04
WASHINGTON, TYNE & WEAR, UNITED KI510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
ROSTAM LTD. 510(k) NO: K042773(TRADITIONAL)
ATTN: ROBERT J STAAB PHONE NO : 201-327-0035
73 FRANKLIN TPK. SE DECISION MADE: 23-NOV-04
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S&C-SELF ETCH PRIMEBOND
S & C POLYMER GMBH 510(k) NO: K042614(TRADITIONAL)
ATTN: CHRISTIAN BOETTCHER PHONE NO : 49 412 14830
ROBERT-BOSCH-STRASSE 5 SE DECISION MADE: 22-NOV-04
ELMSHORN, GERMANY D-25335 510(k) STATEMENT
DEVICE: SHUNTCHECK (PROMETHEUS 1)
SAMUEL NEFF M.D. 510(k) NO: K040021(TRADITIONAL)
ATTN: SAMUEL NEFF PHONE NO : 856-672-0800
17 WHITE HORSE PIKE SE DECISION MADE: 02-NOV-04
SUITE 3 510(k) STATEMENT
HADDON HEIGHTS, NJ 08035-1299
DEVICE: MX MONOAXIAL PEDICLE SCREW
SCIENT'X 510(k) NO: K042964(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 22-NOV-04
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URS LP DIGITAL, MILLENNIUM, RADPRO
SEDECAL S.A. 510(k) NO: K042876(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 18-NOV-04
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR
SEDECAL S.A. 510(k) NO: K043002(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 18-NOV-04
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)
SERADYN INC. 510(k) NO: K042307(ABBREVIATED)
ATTN: JACK ROGERS PHONE NO : 317-610-3823
7998 GEORGETOWN RD. SE DECISION MADE: 03-NOV-04
SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46268
DEVICE: POWDER-FREE VINYL PATIENT EXAMINTION GLOVES
SHIJIAZHUANG MANFUL LIGHT INDUSTRI510(k) NO: K042119(TRADITIONAL)
ATTN: CHEN YUHONG PHONE NO : 861 065 66660125
RM 707, AVIC BLDG, SE DECISION MADE: 03-NOV-04
NO 2 DONG SAN HUAN NAN ROAD 510(k) SUMMARY AVAILABLE FROM FDA
CHAOYANG; BEIJING, CHINA 10002
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG MANFUL LIGHT INDUSTRI510(k) NO: K042120(TRADITIONAL)
ATTN: CHEN YUHONG PHONE NO : 861 065 66660125
RM 707, AVIC BLDG, SE DECISION MADE: 04-NOV-04
NO 2 DONG SAN HUAN NAN ROAD 510(k) SUMMARY AVAILABLE FROM FDA
CHAOYANG; BEIJING, CHINA 10002
DEVICE: 31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K042617(TRADITIONAL)
ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769
51 VALLEY STREAM PARKWAY SE DECISION MADE: 05-NOV-04
E-50 510(k) SUMMARY AVAILABLE FROM FDA
MALVERN, PA 19355
DEVICE: X-LEONARDO
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K042995(SPECIAL)
ATTN: ANA LADINO PHONE NO : 610-448-1785
51 VALLEY STREAM PKWY. SE DECISION MADE: 24-NOV-04
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K043016(TRADITIONAL)
ATTN: PATRICK J LYNCH PHONE NO : 425-557-1825
22010 S.E. 51ST ST. SE DECISION MADE: 16-NOV-04
ISSAQUAH, WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA
SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K042718(TRADITIONAL)
ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769
51 VALLEY STREAM PARKWAY SE DECISION MADE: 12-NOV-04
E-50 510(k) SUMMARY AVAILABLE FROM FDA
MALVERN, PA 19355
DEVICE: THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM
SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K043082(TRADITIONAL)
ATTN: TRACY L GRAY PHONE NO : 763-588-9873
4050 OLSON MEMORIAL HWY SE DECISION MADE: 23-NOV-04
SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55422
DEVICE: SDS-4I
SKYLARK DEVICE & SYSTEMS CO., LTD 510(k) NO: K034005(TRADITIONAL)
ATTN: GEORGE CHIANG PHONE NO : 886 335 87677
4F, 34, SEC. 3, SE DECISION MADE: 18-NOV-04
CHUNG SHAN NORTH RD. 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN)
DEVICE: SMITH & NEPHEW MODULAR HIP
SMITH & NEPHEW, INC. 510(k) NO: K042127(ABBREVIATED)
ATTN: JANET JOHNSON AKIL PHONE NO : 901-399-5153
1450 E. BROOKS RD. SE DECISION MADE: 19-NOV-04
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIGEN HINDFOOT FUSION NAIL
SMITH & NEPHEW, INC. 510(k) NO: K043052(SPECIAL)
ATTN: JANET JOHNSON AKIL PHONE NO : 901-399-5153
1450 E. BROOKS RD. SE DECISION MADE: 24-NOV-04
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOU
SONOTECH, INC. 510(k) NO: K042619(SPECIAL)
ATTN: MARGARET J LARSON PHONE NO : 360-671-9121
774 MARINE DR. SE DECISION MADE: 05-NOV-04
BELLINGHAM, WA 98225 510(k) STATEMENT
DEVICE: T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303
SPECTROS CORPORATION 510(k) NO: K040684(TRADITIONAL)
ATTN: DAVID A BENARON PHONE NO : 650-851-4040
4370 ALPINE ROAD SE DECISION MADE: 05-NOV-04
SUITE 108 510(k) SUMMARY AVAILABLE FROM FDA
PORTOLA VALLEY, CA 94028
DEVICE: UNI-THREAD SPINAL SYSTEM
SPINEVISION, INC. 510(k) NO: K042640(TRADITIONAL)
ATTN: LYNNETTE WHITAKER PHONE NO : 574-269-9776
3003 SUMMIT BLVD. STE 1400 SE DECISION MADE: 23-NOV-04
ATLANTA, GA 30319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM
STANDARD IMAGING, INC. 510(k) NO: K042733(TRADITIONAL)
ATTN: RAYMOND RIDDLE PHONE NO : 608-831-0025
7601 MURPHY DR. SE DECISION MADE: 15-NOV-04
MIDDLETON, WI 53562-2766 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A
STELLARTECH RESEARCH CORP. 510(k) NO: K042909(SPECIAL)
ATTN: JAMES R SANTOS PHONE NO : 408-331-3145
1346 BORDEAUX DR. SE DECISION MADE: 12-NOV-04
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERDIMENSION/BRONCHUS
SUPERDIMENSION LTD. 510(k) NO: K042438(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 S SE DECISION MADE: 08-NOV-04
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SY
SURGICAL LASER TECHNOLOGIES, INC. 510(k) NO: K042211(TRADITIONAL)
ATTN: BOB ROSE PHONE NO : 760-602-3300
147 KEYSTONE DR. SE DECISION MADE: 08-NOV-04
MONTGOMERYVILLE, PA 18936 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICHIP TAG SURGICAL MARKER
SURGICHIP, INC. 510(k) NO: K042555(TRADITIONAL)
ATTN: BRUCE WAXMAN PHONE NO : 561-694-7776
4398 HICKORY DRIVE SE DECISION MADE: 09-NOV-04
PALM GARDENS, FL 33418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
SURGRX, INC. 510(k) NO: K043008(SPECIAL)
ATTN: LINDA OLESON PHONE NO : 650-739-0920
380 PORTAGE AVE. SE DECISION MADE: 17-NOV-04
PALO ALTO, CA 94306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D3 CHROMA
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K042422(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVE. SE DECISION MADE: 15-NOV-04
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARIS DS/COMET
SYNERON MEDICAL LTD. 510(k) NO: K041959(TRADITIONAL)
ATTN: AMIR WALDMAN PHONE NO : 972 67 404616
POB 550 SE DECISION MADE: 08-NOV-04
YOKNEAM ELITE, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM
SYNTHES (USA) 510(k) NO: K042365(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 18-NOV-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES
SYNTHES (USA) 510(k) NO: K042895(SPECIAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 16-NOV-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
SYNTHES (USA) 510(k) NO: K042986(SPECIAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 17-NOV-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SYNTHES CRANIAL PLATES
SYNTHES (USA) 510(k) NO: K042987(SPECIAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 23-NOV-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR
TAIWAN KING STRONG CO., LTD. 510(k) NO: K042652(TRADITIONAL)
ATTN: KE-MEN JEN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 04-NOV-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT
DEVICE: MININEPH HUMAN RHEUMATOID FACTOR KIT
THE BINDING SITE 510(k) NO: K041891(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 05-NOV-04
2425 WEST OLYMPIC BLVD. 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: BINDING SITE IGG SUBLCASS OLYMPUS KITS
THE BINDING SITE 510(k) NO: K042152(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 22-NOV-04
2425 WEST OLYMPIC BLVD. 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: HI-ART SYSTEM
TOMOTHERAPY INCORPORATED 510(k) NO: K042739(SPECIAL)
ATTN: KENNETH D BUROKER PHONE NO : 608-824-2811
1240 DEMING WAY SE DECISION MADE: 03-NOV-04
MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
TOPCON CORP. 510(k) NO: K041367(TRADITIONAL)
ATTN: DONALD H WINFIELD PHONE NO : 201-261-9450
37 WEST CENTURY RD. SE DECISION MADE: 05-NOV-04
PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K043078(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 17-NOV-04
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K043111(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 18-NOV-04
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: TONO-PEN TONOMETER TIP COVER
TRA & ACCESSORIES 510(k) NO: K033146(TRADITIONAL)
ATTN: RICHARD MASTROLEO PHONE NO : 909-305-1944
449 WEST ALLEN AVE. SUITE 107 SE DECISION MADE: 23-NOV-04
SANDIMAS, CA 91773 510(k) STATEMENT
DEVICE: OMNIPULSE MINI, MODEL 2120
TRIMEDYNE, INC. 510(k) NO: K043012(TRADITIONAL)
ATTN: GLENN YEIK PHONE NO : 949-951-3800
15091 BAKE PKWY. SE DECISION MADE: 17-NOV-04
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTE
USA LASER BIOTECH INC. 510(k) NO: K042256(TRADITIONAL)
ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433
12101 CULLEN BLVD., # A SE DECISION MADE: 17-NOV-04
HOUSTON, TX 77047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOL-TIP RF ABLATION SYSTEM
VALLEYLAB 510(k) NO: K042216(TRADITIONAL)
ATTN: CHARLES COPPERBERG PHONE NO : 303-530-6247
5920 LONGBOW DR. SE DECISION MADE: 12-NOV-04
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASC-ALERT
VASC-ALERT, INC. 510(k) NO: K042566(TRADITIONAL)
ATTN: JOHN B KENNEDY PHONE NO : 773-334-8177
1807 WEST SUNNYSIDE AVE. SE DECISION MADE: 08-NOV-04
SUITE 301 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60640
DEVICE: VENTURE WIRE CONTROL CATHETER, MODEL WCC
VELOCIMED INC. 510(k) NO: K042910(SPECIAL)
ATTN: JOHN CARLINE PHONE NO : 763-463-4742
11400 73RD AVE NORTH STE 134 SE DECISION MADE: 22-NOV-04
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO IVENT 201 - PORTABLE VENTILATOR
VERSAMED MEDICAL SYSTEMS, INC. 510(k) NO: K042468(SPECIAL)
ATTN: JERRY KORTEN PHONE NO : 845-770-2840
2 BLUE HILL PLAZA SE DECISION MADE: 17-NOV-04
BLDG. 2, 3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
PEARL RIVER, NY 10965
DEVICE: FUTURABOND NR
VOCO GMBH 510(k) NO: K042670(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 01-NOV-04
BEND, OR 97702 510(k) STATEMENT
DEVICE: VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM
VOLCANO THERAPEUTICS, INC. 510(k) NO: K042188(TRADITIONAL)
ATTN: JAMES FARNWORTH PHONE NO : 916-638-8008
2870 KILGORE RD. SE DECISION MADE: 10-NOV-04
RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FL
VOLCANO THERAPEUTICS, INC. 510(k) NO: K042996(SPECIAL)
ATTN: LORRY HUFFMAN PHONE NO : 916-638-9404
2870 KILGORE RD. SE DECISION MADE: 24-NOV-04
RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI CHEM CAL B
WAKO CHEMICALS, USA, INC. 510(k) NO: K042549(TRADITIONAL)
ATTN: LORI CREASY PHONE NO : 804-714-1932
1600 BELLWOOD RD. SE DECISION MADE: 08-NOV-04
RICHMOND, VA 23237 510(k) STATEMENT
DEVICE: MULTI-LIPID CALIBRATOR
WAKO CHEMICALS, USA, INC. 510(k) NO: K042550(TRADITIONAL)
ATTN: LORI CREASY PHONE NO : 804-714-1932
1600 BELLWOOD RD. SE DECISION MADE: 08-NOV-04
RICHMOND, VA 23237 510(k) STATEMENT
DEVICE: MULTI-CHEM CALIBRATOR A
WAKO CHEMICALS, USA, INC. 510(k) NO: K042551(TRADITIONAL)
ATTN: LORI CREASY PHONE NO : 804-714-1932
1600 BELLWOOD RD. SE DECISION MADE: 16-NOV-04
RICHMOND, VA 23237 510(k) STATEMENT
DEVICE: OTOMIMIX
WALTER LORENZ SURGICAL, INC. 510(k) NO: K042516(TRADITIONAL)
ATTN: KIM REED PHONE NO : 904-741-9443
1520 TRADEPORT DR. SE DECISION MADE: 08-NOV-04
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM
WANDONG MEDICAL 510(k) NO: K042948(TRADITIONAL)
ATTN: WANG WEIMIN PHONE NO : 86 10 65477301
NO. 7 SANJIANFANG NANLI SE DECISION MADE: 03-NOV-04
CHAOYANG DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 100024 THIRD PARTY REVIEW
DEVICE: PERFECTA FEMORAL STEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K031402(TRADITIONAL)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732
5677 AIRLINE RD. SE DECISION MADE: 22-NOV-04
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE
ZEST ANCHORS, INC. 510(k) NO: K042466(SPECIAL)
ATTN: PAUL ZUEST PHONE NO : 760-743-7744
2061 WINERIDGE PL., SUITE 100 SE DECISION MADE: 24-NOV-04
ESCONDIDO, CA 92029 510(k) STATEMENT
DEVICE: SILHOUETTE SPINAL FIXATION SYSTEM
ZIMMER SPINE, INC. 510(k) NO: K042702(SPECIAL)
ATTN: TIM CRABTREE PHONE NO : 952-857-5631
7375 BUSH LAKE RD. SE DECISION MADE: 23-NOV-04
MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOU
ZIMMER TRABECULAR 510(k) NO: K043061(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 23-NOV-04
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
ZIMMER, INC. 510(k) NO: K042337(SPECIAL)
ATTN: DALENE BINKLEY PHONE NO : 574-372-4907
P.O. BOX 708 SE DECISION MADE: 04-NOV-04
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES
ZIMMER, INC. 510(k) NO: K042761(TRADITIONAL)
ATTN: NOAH BARTSCH PHONE NO : 574-371-8552
P.O. BOX 708 SE DECISION MADE: 17-NOV-04
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS,
ZIMMER, INC. 510(k) NO: K042776(SPECIAL)
ATTN: KAREN CAIN PHONE NO : 574-372-4485
P.O. BOX 708 SE DECISION MADE: 04-NOV-04
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 285
TOTAL WITH SUMMARIES 227
TOTAL WITH STATEMENTS 58
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