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Medical Devices
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January 1999 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-JAN-99 THROUGH 31-JAN-99
DEVICE: EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL
A.STEIN-REGULATORY AFFAIRS CONSULT510(k) NO: K982754(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 979 20673
P.O.B. 454 SE DECISION MADE: 08-JAN-99
GINOT SHOMRON, ISRAEL 44853 510(k) STATEMENT
DEVICE: SYSTEM U3 FOR NITROFURANTOIN
AB BIODISK 510(k) NO: K983565(TRADITIONAL)
ATTN: ANNE BOLMSTROM PHONE NO : 468 730 0760
DALVAGEN 10 SE DECISION MADE: 05-JAN-99
SOLNA, SWEDEN 16956 510(k) STATEMENT
DEVICE: ABBOTT PLUM A+ INFUSION PUMP
ABBOTT LABORATORIES 510(k) NO: K982159(TRADITIONAL)
ATTN: DAVID T GUZEK PHONE NO : 847-937-3216
1401 SHERIDAN RD. SE DECISION MADE: 12-JAN-99
NORTH CHICAGO, IL 60064-4000 510(k) STATEMENT
DEVICE: APOB
ABBOTT LABORATORIES 510(k) NO: K983281(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1920 HURD SE DECISION MADE: 26-JAN-99
IRVING, TX 75062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APOLIPOPROTEIN A1
ABBOTT LABORATORIES 510(k) NO: K983289(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1920 HURD SE DECISION MADE: 29-JAN-99
IRVING, TX 75062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UALB
ABBOTT LABORATORIES 510(k) NO: K983774(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1920 HURD SE DECISION MADE: 28-JAN-99
IRVING, TX 75062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVX
ADORNO/ROGERS TECHNOLOGY, INC 510(k) NO: K984367(TRADITIONAL)
ATTN: PAUL GIBB PHONE NO : 512-474-7267
101 WEST 6TH ST. STE. 407 SE DECISION MADE: 28-JAN-99
AUSTIN, TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENOMETER
ADVANCED MEDICAL TECHNOLOGY LTD 510(k) NO: K983900(ABBREVIATED)
ATTN: WILLIAM E MCKAY PHONE NO : 801-944-9977
9712 S. ALTAMONT DRIVE SE DECISION MADE: 29-JAN-99
SANDY, UT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERRAD 50 STERILIZER
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K981625(TRADITIONAL)
ATTN: KEVIN CORRIGAN PHONE NO : 949-453-6410
33 TECHNOLOGY DR. SE DECISION MADE: 11-JAN-99
IRVINE, CA 92718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
ALCON LABORATORIES 510(k) NO: K984575(SPECIAL)
ATTN: RALPH H LARSEN PHONE NO : 817-551-4702
6201 SOUTH FREEWAY SE DECISION MADE: 14-JAN-99
FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLEGIANCE PORTA-WARM MATTRESS
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K982652(TRADITIONAL)
ATTN: PATRICIA SHARPE-GREGG PHONE NO : 847-578-3636
1500 WAUKEGAN ROAD SE DECISION MADE: 21-JAN-99
BUILDING MP-WM 510(k) SUMMARY AVAILABLE FROM FDA
MCGAW PARK, IL 60085
DEVICE: ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES
ALLEGIANCE HEALTHCARE SDN. BHD. 510(k) NO: K983962(SPECIAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD SE DECISION MADE: 08-JAN-99
BUILDING K 510(k) SUMMARY AVAILABLE FROM FDA
MCGAW PARK, IL 60085
DEVICE: AMPLAID A311 SERIES
AMPLIFON S.P.A. 510(k) NO: K983712(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 12-JAN-99
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPLAID A315 AND A319
AMPLIFON S.P.A. 510(k) NO: K983915(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 29-JAN-99
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM
ANGIODYNAMICS, INC. 510(k) NO: K982346(TRADITIONAL)
ATTN: BRIAN KUNST PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 29-JAN-99
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: MCAS (MODULAR CLIP APPLIER SYSTEM)
APPLIED MEDICAL RESOURCES 510(k) NO: K983744(TRADITIONAL)
ATTN: HOWARD V ROWE PHONE NO : 949-582-6120
26051 MERIT CIRCLE, #104 SE DECISION MADE: 21-JAN-99
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAI
ASPECT VISION CARE, LTD. 510(k) NO: K982997(TRADITIONAL)
ATTN: MARTIN S KNOPF PHONE NO : 732-303-1205
90 WETS MAIN STREET SE DECISION MADE: 20-JAN-99
FREEHOLD, NJ 07728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVL OMNI MODULAR ANALYZER
AVL SCIENTIFIC CORP. 510(k) NO: K990092(TRADITIONAL)
ATTN: RANDY BYRD PHONE NO : 707-587-4040
33 MANSELL COURT SE DECISION MADE: 29-JAN-99
ROSWELL, GA 30077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASKINA HYDROCOLLOID/THIN
B. BRAUN MEDICAL, INC. 510(k) NO: K973227(TRADITIONAL)
ATTN: MARK S ALSBERGE PHONE NO : 610-691-5400
824 TWELFTH AVE. SE DECISION MADE: 28-JAN-99
BETHLEHEM, PA 18018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTROCAN SAFETY IV CATHETER
B. BRAUN MEDICAL, INC. 510(k) NO: K982805(TRADITIONAL)
ATTN: MARK S ALSBERGE PHONE NO : 610-997-4360
824 12TH AVE. SE DECISION MADE: 14-JAN-99
BETHLEHEM, PA 18018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
BAYER CORP. 510(k) NO: K982328(TRADITIONAL)
ATTN: GABRIEL J MURACA JR. PHONE NO : 914-631-8000
511 BENEDICT AVE. SE DECISION MADE: 29-JAN-99
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6004 NIBP MONITOR WITH TEMPERATURE
BCI INTERNATIONAL, INC. 510(k) NO: K983796(TRADITIONAL)
ATTN: DONALD J ALEXANDER PHONE NO : 414-542-3100
N7 W22025 JOHNSON ROAD SE DECISION MADE: 22-JAN-99
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT
BECKMAN COULTER, INC. 510(k) NO: K984152(TRADITIONAL)
ATTN: LUCINDA STOCKERT PHONE NO : 714-961-3777
200 S. KRAEMER BLVD., W-104 SE DECISION MADE: 29-JAN-99
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT
BECKMAN COULTER, INC. 510(k) NO: K984402(TRADITIONAL)
ATTN: LUCINDA STOCKERT PHONE NO : 714-961-3777
200 SOUTH KRAEMER BLVD.,W-337 SE DECISION MADE: 29-JAN-99
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES
BELMONT EQUIPMENT CORP. 510(k) NO: K983661(TRADITIONAL)
ATTN: JOHN E COLLINS PHONE NO : 732-469-5000
101 BELMONT DR. SE DECISION MADE: 12-JAN-99
SOMERSET, NJ 08873-1204 510(k) STATEMENT
DEVICE: BICON BONE SCREW SYSTEM
BICON, INC. 510(k) NO: K982488(TRADITIONAL)
ATTN: VINCENT J MORGAN PHONE NO : 617-524-4443
1153 CENTRE ST., SUITE 21 SE DECISION MADE: 26-JAN-99
BOSTON, MA 02130 510(k) STATEMENT
DEVICE: XYZ SYSTEM
BIO-MONITORING INTERNATIONAL CORPO510(k) NO: K983550(TRADITIONAL)
ATTN: ANAND AKERKAR PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 07-JAN-99
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 5
BIO-RAD LABORATORIES 510(k) NO: K984477(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO ROAD SE DECISION MADE: 29-JAN-99
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5
BIO-RAD LABORATORIES 510(k) NO: K984626(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-594-1285
9500 JERONIMO ROAD SE DECISION MADE: 29-JAN-99
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10
BIO-RAD LABORATORIES 510(k) NO: K990017(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO ROAD SE DECISION MADE: 25-JAN-99
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38
BIO-RAD LABORATORIES 510(k) NO: K990149(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO ROAD SE DECISION MADE: 26-JAN-99
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01
BIO-RAD LABORATORIES 510(k) NO: K990150(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO ROAD SE DECISION MADE: 26-JAN-99
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01
BIO-RAD LABORATORIES 510(k) NO: K990161(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO ROAD SE DECISION MADE: 28-JAN-99
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01
BIO-RAD LABORATORIES 510(k) NO: K990162(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO ROAD SE DECISION MADE: 28-JAN-99
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: LACTOSORB MENISCAL REPAIR DEVICE
BIOMET, INC. 510(k) NO: K982095(TRADITIONAL)
ATTN: MARY L VERSTYNEN PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 27-JAN-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: THE NEW BIO-MOORE ENDO HEADS
BIOMET, INC. 510(k) NO: K984028(TRADITIONAL)
ATTN: TRACEY J BICKEL PHONE NO : 219-372-1761
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 19-JAN-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: BIOCLOT APC SENSITIVITY
BIOPOOL INTL., INC. 510(k) NO: K983898(TRADITIONAL)
ATTN: MICHAEL D BICK PHONE NO : 805-654-0643
6025 NICOLLE ST., SUITE D SE DECISION MADE: 06-JAN-99
VENTURA, CA 93003 510(k) STATEMENT
DEVICE: GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M
BIOTRONIK, INC. 510(k) NO: K982272(TRADITIONAL)
ATTN: DAVID MAKANANI PHONE NO : 888-345-0374
6024 JEAN RD. SE DECISION MADE: 08-JAN-99
LAKE OSWEGO, OR 97035-5369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR
BOEHRINGER MANNHEIM CORP. 510(k) NO: K984425(TRADITIONAL)
ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723
9115 HAGUE ROAD SE DECISION MADE: 20-JAN-99
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTAL STERLIZATION TRAY/CASSETTE
BRASSELER USA I, L.P. 510(k) NO: K983223(TRADITIONAL)
ATTN: COURTNEY S PARADICE PHONE NO : 770-355-9980
1679 KELLOGG SPRINGS DRIVE SE DECISION MADE: 14-JAN-99
ATLANTA, GA 30338 510(k) STATEMENT
DEVICE: FLUOROTEX SURGICAL MESH
BRIDGER BIOMED, INC. 510(k) NO: K984197(TRADITIONAL)
ATTN: BRUCE G RUEFER PHONE NO : 406-586-7666
2430 NORTH 7TH AVE., SUITE 4 SE DECISION MADE: 07-JAN-99
BOZEMAN, MT 59715 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTUM, INTRAORAL CAMERA SYSTEM
CAMSIGHT, INC. 510(k) NO: K983739(TRADITIONAL)
ATTN: W.EDWARD JOHANSEN PHONE NO : 310-826-4902
11661 SAN VICENTE BOULEVARD SE DECISION MADE: 19-JAN-99
LOS ANGELES, CA 90049 510(k) STATEMENT
DEVICE: MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006,
CARDIAC PATHWAYS CORP. 510(k) NO: K982540(TRADITIONAL)
ATTN: ERIN DIGNAN PHONE NO : 408-737-0505
995 BENECIA AVE. SE DECISION MADE: 27-JAN-99
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEART-LIFT BALLOON POSITIONER
CARDIOTHORACIC SYSTEMS, INC. 510(k) NO: K982419(TRADITIONAL)
ATTN: MIKE BILLIG PHONE NO : 408-342-1700
10600 NORTH TANTAU AVENUE SE DECISION MADE: 13-JAN-99
CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESIDE ALKALINE PHOSPHATASE
CARESIDE, INC. 510(k) NO: K990024(TRADITIONAL)
ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767
6100 BRISTOL PARKWAY SE DECISION MADE: 13-JAN-99
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPMI TWINER SURGICAL MICROSCOPE
CARL ZEISS, INC. 510(k) NO: K983868(TRADITIONAL)
ATTN: SCOTT A MARGOLIN PHONE NO : 914-681-7880
ONE ZEISS DR. SE DECISION MADE: 29-JAN-99
THORNWOOD, NY 10594 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASETTE
CELL ROBOTICS, INC. 510(k) NO: K983673(TRADITIONAL)
ATTN: RONALD K LOHRDING PHONE NO : 505-343-1131
2715 BROADBENT PARKWAY, NE SE DECISION MADE: 15-JAN-99
ALBUGUERQUE, NM 87107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSTAT 2
CHEMLINK LABORATORIES LLC 510(k) NO: K984485(TRADITIONAL)
ATTN: KARI E MAVIAN PHONE NO : 202-393-3903
122 C STREET, N.W., SE DECISION MADE: 13-JAN-99
SUITE 740 510(k) STATEMENT
WASHINGTON, DC 20001
DEVICE: FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS
CIBA VISION CORP. 510(k) NO: K984273(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 770-418-3897
11460 JOHN'S CREEK PARKWAY SE DECISION MADE: 25-JAN-99
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (
CL-TINTERS 510(k) NO: K984259(TRADITIONAL)
ATTN: MARTIN S KNOPF PHONE NO : 732-303-1205
6 SHADOWBROOK DRIVE SE DECISION MADE: 21-JAN-99
COLTS NECK, NJ 07722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRZONE PEAK FLOWMETER
CLEMENT CLARKE INTL., LTD. 510(k) NO: K982334(TRADITIONAL)
ATTN: M J WILKINSON PHONE NO : 011 44 0127941496
EDINBURGH WAY SE DECISION MADE: 14-JAN-99
HARLOW, UNITED KINGDOM CM20 2TT 510(k) STATEMENT
DEVICE: COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
COBE CARDIOVASCULAR, INC. 510(k) NO: K984456(SPECIAL)
ATTN: LYNNE LEONARD PHONE NO : 303-467-6586
14401 WEST 65TH WAY SE DECISION MADE: 11-JAN-99
ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARIETEX
COGENT 510(k) NO: K982532(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH ST. N.W. SE DECISION MADE: 20-JAN-99
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOSTAT II ANA SCREEN ELISA
COGENT DIAGNOTICS LTD. 510(k) NO: K983655(TRADITIONAL)
ATTN: DANIELLE M KNIGHT PHONE NO : 441 314 457111
PENTLANDS SCIENCE PARK SE DECISION MADE: 28-JAN-99
BUSH LOAN, PENICUIK 510(k) STATEMENT
MIDLOTHIAN, SCOTLAND, UNITED KINGDOM EH26 OPL
DEVICE: COMPEED PSORIASIS DRESSING
COLOPLAST CORP. 510(k) NO: K982493(TRADITIONAL)
ATTN: SYDNEY LILLY PHONE NO : 770-281-8260
1955 WEST OAK CIRCLE SE DECISION MADE: 28-JAN-99
MARIETTA, GA 30062-2249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MECHANICAL WHEELCHAIR
COLOURS 'N MOTION 510(k) NO: K984354(TRADITIONAL)
ATTN: JOHN G BOX PHONE NO : 714-978-1440
1591 SOUTH SINCLAIR ST. SE DECISION MADE: 28-JAN-99
ANAHEIM, CA 92806 510(k) STATEMENT
DEVICE: BIOSONIC ULTRASONIC SCALER SYSTEM
COLTENE/WHALEDENT, INC. 510(k) NO: K983727(TRADITIONAL)
ATTN: H.J. VOGELSTEIN PHONE NO : 201-512-8000
750 CORPORATE DR. SE DECISION MADE: 20-JAN-99
MAHWAH, NJ 07430-2009 510(k) STATEMENT
DEVICE: ELECTROSURGICAL DISPERSIVE ELECTRODE
ONMED CORP. 510(k) NO: K983782(TRADITIONAL)
ATTN: IRA D DUESLER, JR PHONE NO : 315-797-8375
310 BROAD ST. SE DECISION MADE: 25-JAN-99
UTICA, NY 13501-1203 510(k) STATEMENT
DEVICE: OVUM PICK-UP ASPIRATION NEEDLES
COOK OB/GYN 510(k) NO: K983593(TRADITIONAL)
ATTN: DEBBIE SCHMITT PHONE NO : 812-829-6500
1100 W. MORGAN STREET SE DECISION MADE: 21-JAN-99
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHAIT CECOSTOMY CATHETER
COOK, INC. 510(k) NO: K982500(TRADITIONAL)
ATTN: APRIL LAVENDER PHONE NO : 800-346-2686
925 SOUTH CURRY PIKE SE DECISION MADE: 27-JAN-99
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROWE DUAL-CHECK VALVE
COOK, INC. 510(k) NO: K983217(TRADITIONAL)
ATTN: APRIL LAVENDER PHONE NO : 800-346-2686
925 SOUTH CURRY PIKE SE DECISION MADE: 20-JAN-99
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MPS GRAVITY FLOW CONTROL SET
CRITICAL DEVICE CORP. 510(k) NO: K983926(TRADITIONAL)
ATTN: DAN HYUN PHONE NO : 714-257-0470
499 NIBUS ST., SUITE E SE DECISION MADE: 20-JAN-99
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM
CRYOSURGERY, INC. 510(k) NO: K982506(TRADITIONAL)
ATTN: RONALD A MCDOW PHONE NO : 615-646-2672
P.O. BOX 50035 SE DECISION MADE: 27-JAN-99
NASHVILLE, TN 37205-0035 510(k) STATEMENT
DEVICE: CYNOSURE ERASURE LASER
CYNOSURE, INC. 510(k) NO: K984517(SPECIAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 20-JAN-99
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL)
DADE BEHRING, INC. 510(k) NO: K983849(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
BLDG. 500 MAIL BOX 514 SE DECISION MADE: 11-JAN-99
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB T
DADE BEHRING, INC. 510(k) NO: K984067(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
GLASGOW SITE SE DECISION MADE: 13-JAN-99
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
DANEK MEDICAL, INC. 510(k) NO: K982875(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 19-JAN-99
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF TSRH SPINAL SYSTEM
DANEK MEDICAL, INC. 510(k) NO: K984522(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 06-JAN-99
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC
DATEX-OHMEDA 510(k) NO: K990132(SPECIAL)
ATTN: DANIEL KOSEDNAR PHONE NO : 608-221-1551
P.O. BOX 7550 SE DECISION MADE: 21-JAN-99
MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS
DEN-TAL-EZ, INC. 510(k) NO: K983574(TRADITIONAL)
ATTN: WILLIAM GUSCOTT PHONE NO : 717-291-1161
1816 COLONIAL VILLAGE LN. SE DECISION MADE: 08-JAN-99
LANCASTER, PA 17601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN
DENTSPLY INTL. 510(k) NO: K983966(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVENUE SE DECISION MADE: 29-JAN-99
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R-30 AESTHETIC RESTORATIVE
DENTSPLY INTL. 510(k) NO: K984387(TRADITIONAL)
ATTN: P JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE SE DECISION MADE: 13-JAN-99
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIMX LOW BACK SYSTEM
DEPUY MOTECH ACROMED 510(k) NO: K984348(TRADITIONAL)
ATTN: PAM CORSILLO PHONE NO : 216-432-6842
3303 CARNEGIE AVE. SE DECISION MADE: 20-JAN-99
CLEVELAND, OH 44115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VSP SYSTEM
DEPUY MOTECH ACROMED 510(k) NO: K984350(TRADITIONAL)
ATTN: PAM CORSILLO PHONE NO : 216-432-6842
3303 CARNEGIE AVE. SE DECISION MADE: 20-JAN-99
CLEVELAND, OH 44115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY PROFILE FEMORAL HIP WITH POROCOAT
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K984459(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 219-372-7455
700 ORTHOPAEDIC DR. SE DECISION MADE: 28-JAN-99
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K984541(SPECIAL)
ATTN: ARLENE C SAULL PHONE NO : 219-372-7176
700 ORTHOPAEDIC DR. SE DECISION MADE: 14-JAN-99
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY
DEPUY, INC. 510(k) NO: K984158(TRADITIONAL)
ATTN: ARLENE C SAULL PHONE NO : 219-372-7176
700 ORTHOPAEDIC DRIVE SE DECISION MADE: 28-JAN-99
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K984132(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 28-JAN-99
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLADDERMANAGER PCI 5000 MODEL 1002
DIAGNOSTIC ULTRASOUND CORP. 510(k) NO: K982568(TRADITIONAL)
ATTN: GERALD MCMORROW PHONE NO : 206-867-1348
18109 N.E. 76TH ST. SE DECISION MADE: 25-JAN-99
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IS-RUBELLA IGG TEST SYSTEM
DIAMEDIX CORP. 510(k) NO: K981729(TRADITIONAL)
ATTN: LYNNE STIRLING PHONE NO : 305-324-2300
2140 NORTH MIAMI AVE. SE DECISION MADE: 28-JAN-99
MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROENDOSCOPE, "MINIATURIZED BIOPSY SCOPE"
DOFI COMMUNICATIONS 510(k) NO: K983527(TRADITIONAL)
ATTN: TONY ANTHONY PHONE NO : 212-397-8075
150 WEST 51ST STREET, #1108 SE DECISION MADE: 19-JAN-99
NEW YORK, NY 10019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACSCACHE
DOME IMAGING SYSTEMS, INC 510(k) NO: K983815(TRADITIONAL)
ATTN: MORTEZA MINAEE PHONE NO : 781-895-1155
400 FIFTH AVENUE SE DECISION MADE: 14-JAN-99
WAITHAM, MA 02154 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN
DOWLING TEXTILE MFG. CO. 510(k) NO: K982058(TRADITIONAL)
ATTN: TIM CUMMINS PHONE NO : 770-957-3981
615 MACON RD. SE DECISION MADE: 14-JAN-99
MCDONOUGH, GA 30253 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRAGER OXYLOG 2000
DRAGER, INC. 510(k) NO: K984577(SPECIAL)
ATTN: HARALD KNEUER PHONE NO : 215-721-6910
3136 QUARRY RD. SE DECISION MADE: 22-JAN-99
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE
E. BENSON HOOD LABORATORIES, INC. 510(k) NO: K983878(TRADITIONAL)
ATTN: ANTHONY M SACCHETTI PHONE NO : 781-826-7573
575 WASHNGTON ST. SE DECISION MADE: 29-JAN-99
PEMBROKE, MA 02359 510(k) STATEMENT
DEVICE: KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIG
EASTMAN KODAK CO. 510(k) NO: K983905(TRADITIONAL)
ATTN: JUDITH A WALLACE PHONE NO : 716-726-6763
901 ELMGROVE RD. SE DECISION MADE: 25-JAN-99
ROCHESTER, NY 14650 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM
EFRATGO, LTD. HI TECH BIO-SURGICAL510(k) NO: K983814(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 14-JAN-99
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI SPINELINK SYSTEM
ELECTRO-BIOLOGY, INC. 510(k) NO: K984027(TRADITIONAL)
ATTN: JON CAPAROTTA PHONE NO : 973-299-9022
100 INTERPACE PKWY. SE DECISION MADE: 19-JAN-99
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE
ELEKTA INSTRUMENTS, INC. 510(k) NO: K983678(TRADITIONAL)
ATTN: PAUL L SUMNER PHONE NO : 800-535-7355
3155 NORTHWOODS PRKWY N.W. SE DECISION MADE: 15-JAN-99
NORCROSS, GA 30071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAGABOND SOFT RESTRAINT SYSTEM
EMERGENT INNOVATIONS, LTD. 510(k) NO: K982178(TRADITIONAL)
ATTN: DUANE R ELLIOTT PHONE NO : 317-726-7036
PO BOX 40773 SE DECISION MADE: 26-JAN-99
INDIANAPOLIS, IN 46240 510(k) STATEMENT
DEVICE: BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET
EMOX 911 CC 510(k) NO: K984082(TRADITIONAL)
ATTN: IVOR DUNCAN PHONE NO : 272 185 46006
P.O. BOX 79 SE DECISION MADE: 28-JAN-99
SOMERSET WEST, SOUTH AFRICA 7129 510(k) STATEMENT
DEVICE: ENDIUS SPINE ENDOSCOPE
ENDIUS INC. 510(k) NO: K982819(TRADITIONAL)
ATTN: JOSEPH RESS PHONE NO : 617-965-7714
45 PONTIAC ROAD SE DECISION MADE: 27-JAN-99
NEWTON, MA 02468 510(k) STATEMENT
DEVICE: VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)
ENDOSONICS CORP. 510(k) NO: K982329(TRADITIONAL)
ATTN: ADAM D SAVAKUS PHONE NO : 916-638-8008
2870 KIGORE RD. SE DECISION MADE: 14-JAN-99
RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS PEEP VALVES- ADJUSTABLE
ENGINEERED MEDICAL SYSTEMS 510(k) NO: K983920(TRADITIONAL)
ATTN: JEFF QUINN PHONE NO : 317-872-5500
8529 ZIONSVILLE RD. SE DECISION MADE: 22-JAN-99
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROMPT L-POP
ESPE DENTAL AG 510(k) NO: K984246(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 49 815 2700359
ESPE PLATZ SE DECISION MADE: 08-JAN-99
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCEM
ESPE DENTAL AG 510(k) NO: K984248(TRADITIONAL)
ATTN: ANDREA PETERMANN PHONE NO : 49 815 2700395
ESPE PLATZ SE DECISION MADE: 08-JAN-99
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUE VALUE LINE OF ELECTROSURGICAL ELECTRODES, MODEL #'S 421-429
GEIGER MEDICAL TECHNOLOGIES, INC. 510(k) NO: K983852(TRADITIONAL)
ATTN: JOHN BOTTJER PHONE NO : 949-240-7584
24040 CAMINO DEL AVION, A-195 SE DECISION MADE: 28-JAN-99
MONARCH BEACH, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAGE 7
GENERAL ELECTRIC MEDICAL SYSTEM 510(k) NO: K984167(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 414-544-3894
3200 N. GRANDVIEW BLVD. SE DECISION MADE: 12-JAN-99
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY
GENZYME DIAGNOSTICS 510(k) NO: K983399(TRADITIONAL)
ATTN: BARBARA PIZZA PHONE NO : 617-252-7953
ONE KENDALL SQUARE SE DECISION MADE: 11-JAN-99
CAMBRIDGE, MA 02139-1562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE
GLOVE SEAL SDN BHD 510(k) NO: K983570(TRADITIONAL)
ATTN: VINAYAGAN RAMALINGAM PHONE NO : 603 651 3773
11-2 JALAN SRI HARTAMAS 7 SE DECISION MADE: 14-JAN-99
KUALA LUMPUR, MALAYSIA 50480 510(k) STATEMENT
DEVICE: GOLDMAN MANUAL TONOMETER
GOLDEN VISION, INC. 510(k) NO: K981432(TRADITIONAL)
ATTN: ANDRES R QUIROZ PHONE NO : 305-270-0877
7436 S.W. 117TH AVE.,SUITE 103 SE DECISION MADE: 12-JAN-99
MIAMI, FL 33183-3816 510(k) STATEMENT
DEVICE: GYRUS HYSTEROSCOPIC RESECTOSCOPE
GYRUS MEDICAL 510(k) NO: K982771(TRADITIONAL)
ATTN: DAVID KAY PHONE NO :
ST. MELLONS SE DECISION MADE: 21-JAN-99
CARDIFF, UNITED KINGDOM CF3 OLT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERCATOR
HARLEY STREET SOFTWARE LTD. 510(k) NO: K982384(TRADITIONAL)
ATTN: BRUCE WEBSTER PHONE NO : 250 744 1822
771 VANALMAN AVE. SE DECISION MADE: 27-JAN-99
VICTORIA, CANADA V87388 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS
HEALTHLINE IMPLANTS, INC. 510(k) NO: K981954(TRADITIONAL)
ATTN: WILLIAM SIMMONS PHONE NO : 740-465-5204
832 MARSEILLES-GALION RD W SE DECISION MADE: 25-JAN-99
MARION, OH 510(k) STATEMENT
DEVICE: HEWLETT-PACKARD M1205A VIRIDIA 24 CT
HEWLETT-PACKARD CO. 510(k) NO: K981376(TRADITIONAL)
ATTN: DAVID OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 04-JAN-99
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K
HEWLETT-PACKARD GMBH 510(k) NO: K990125(SPECIAL)
ATTN: EGON PFEIL PHONE NO : 497 031 1142243
HERRENBERGER STR. 110-140 SE DECISION MADE: 29-JAN-99
BOEBLINGEN, GERMANY 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYST
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K984274(TRADITIONAL)
ATTN: JAMES JOCHEN ROGERS PHONE NO : 800-800-3106
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 25-JAN-99
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES
HOWMEDICA INC. 510(k) NO: K983885(TRADITIONAL)
ATTN: JOSEPH VOLPE PHONE NO : 201-507-6695
359 VETERANS BOULEVARD SE DECISION MADE: 29-JAN-99
RUTHERFORD, NJ 07070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS
HOWMEDICA OSTEONICS 510(k) NO: K990059(TRADITIONAL)
ATTN: KATE SUTTON PHONE NO : 201-825-4900
59 ROUTE 17 SE DECISION MADE: 28-JAN-99
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF: RHEO DOPPLEX II
HUNTLEIGH HEALTHCARE, INC. 510(k) NO: K984307(TRADITIONAL)
ATTN: AUDREY WITKO PHONE NO : 800-223-1218
227 RT. 33 EAST SE DECISION MADE: 12-JAN-99
MANALAPAN, NJ 07726-8362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNN SCOUT
I.S.G. TECHNOLOGIES, INC. 510(k) NO: K982570(TRADITIONAL)
ATTN: CAROL NAKAGAWA PHONE NO : 905 672 2100
6509 AIRPORT RD. SE DECISION MADE: 13-JAN-99
MISSISSAUGA, ONTARIO, CANADA L4V 1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYBER-LASE 2000 CURING AND WHITENING LASER
ICS OF NORTH AMERICA, INC. 510(k) NO: K983654(TRADITIONAL)
ATTN: ALAN A CREAMER PHONE NO : 619-558-9203
10054 MESA RIDGE CT. SE DECISION MADE: 12-JAN-99
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
IDEM 510(k) NO: K983832(TRADITIONAL)
ATTN: DONNA WARD PHONE NO : 800-947-6334
4814 EAST SECOND STREET SE DECISION MADE: 25-JAN-99
BENICIA, CA 94510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING S
IMAGE TECHNOLOGIES CORP. 510(k) NO: K983567(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 07-JAN-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMATION TRIMATIC DIGITAL SYSTEM
IMATION CORP. 510(k) NO: K984252(TRADITIONAL)
ATTN: STEPHEN G SLAVENS PHONE NO : 651-704-3536
1 IMATION PLACE, DIS-4B-75 SE DECISION MADE: 25-JAN-99
OAKDALE, MN 55128-3414 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 &
IMCOR 510(k) NO: K983563(TRADITIONAL)
ATTN: ROBERT S URA PHONE NO : 888-462-6728
8000 WEST 78TH ST., SUITE 115 SE DECISION MADE: 11-JAN-99
EDINA, MN 55439 510(k) STATEMENT
DEVICE: OSSEOTITE DENTAL IMPLANTS
IMPLANT INNOVATIONS, INC. 510(k) NO: K983347(TRADITIONAL)
ATTN: WILLIAM G CONETY PHONE NO : 800-443-8166
4555 RIVERSIDE DR. SE DECISION MADE: 06-JAN-99
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER
INNOVASIVE DEVICES, INC. 510(k) NO: K983560(TRADITIONAL)
ATTN: ERIC BANNON PHONE NO : 508-460-8229
734 FOREST ST. SE DECISION MADE: 28-JAN-99
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELIS
INOVA DIAGNOSTICS, INC. 510(k) NO: K984137(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 619-586-9900
10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 28-JAN-99
SAN DIEGO, CA 92131 510(k) STATEMENT
DEVICE: FIELD EFFECTS MRI SYSTEM
INTERMAGNETICS GENERAL CORPORATION510(k) NO: K983902(TRADITIONAL)
ATTN: IAN L PYKETT PHONE NO : 518-782-1122
450 OLD NISKAYUNA ROAD SE DECISION MADE: 07-JAN-99
P.O. BOX 461 510(k) SUMMARY AVAILABLE FROM FDA
LATHAM, NY 12110-0461
DEVICE: DUAL VIAL CREATININE REAGENT
INTERSECT SYSTEMS, INC. 510(k) NO: K983937(ABBREVIATED)
ATTN: JOAN CATHEY PHONE NO : 360-577-1062
P.O. BOX 2219 SE DECISION MADE: 06-JAN-99
LONGVIEW, WA 98632 510(k) STATEMENT
DEVICE: EXHALATION VALVE
INTERSURGICAL, INC. 510(k) NO: K984481(TRADITIONAL)
ATTN: THOMAS R GUNERMAN PHONE NO : 315-451-2900
417 ELECTRONICS PKWY. SE DECISION MADE: 29-JAN-99
LIVERPOOL, NY 13088 510(k) STATEMENT
DEVICE: INVACARE CPAP
INVACARE CORP. 510(k) NO: K982242(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-329-6569
ONE INVACARE WAY SE DECISION MADE: 27-JAN-99
P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44036-2125
DEVICE: MODEL ACTION AT II MANUAL WHEELCHAIR
INVACARE CORP. 510(k) NO: K984447(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-329-6000
1200 TAYLOR ST. SE DECISION MADE: 08-JAN-99
ELYRIA, OH 44035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-SIGN I (R&D PROJECT DW263 #24)
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K984451(TRADITIONAL)
ATTN: PETER P MANCUSO PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 19-JAN-99
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: MAINBOND A
J.F. JELENKO & CO., INC. 510(k) NO: K984140(TRADITIONAL)
ATTN: TRIDIB DASGUPTA PHONE NO : 800-431-1785
99 BUSINESS PARK DR. SE DECISION MADE: 13-JAN-99
ARMONK, NY 10504 510(k) STATEMENT
DEVICE: JMS DIALYZER PRIMING SET
JMS CO., LTD. 510(k) NO: K983707(TRADITIONAL)
ATTN: TETSUHARU HIROSE PHONE NO : 818 224 35806
12-17, KAKO-MACHI, NAKA-KU SE DECISION MADE: 08-JAN-99
HIROSHIMA, JAPAN 730-8652 510(k) STATEMENT
DEVICE: TALKING DIGITAL THERMOMETER, MODEL KV-171
K-JUMP HEALTH CO., LTD. 510(k) NO: K984553(TRADITIONAL)
ATTN: ROBERT J ZAPPA PHONE NO : 303-271-0300
720 CORPORATE CIRCLE, SUITE R SE DECISION MADE: 14-JAN-99
GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS
KAMIYA BIOMEDICAL CO. 510(k) NO: K984045(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 25-JAN-99
SEATTLE, WA 98188-3412 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA MONOPOLAR VAPORIZATION ELECTRODES
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K983569(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 08-JAN-99
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DCI ENDOSCOPE
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K984369(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 29-JAN-99
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAVO KEY LASER 1242
KAVO AMERICA 510(k) NO: K983100(TRADITIONAL)
ATTN: DOUGLAS COCHRANE PHONE NO : 847-550-6800
340 EAST MAIN STREET SE DECISION MADE: 27-JAN-99
LAKE ZURICH, IL 60047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
KILANG BARANGAN GETAH DIOH 510(k) NO: K984127(TRADITIONAL)
ATTN: NORLI MANIFF PHONE NO : 606 481 6145
LOT 9, KAWASAN PERINDUSTRIAN SE DECISION MADE: 25-JAN-99
DIOH, KUALA PILAH 510(k) STATEMENT
NEGERI SEMBILAN, MALAYSIA 72000
DEVICE: KLS-MARIN INTRAORAL ZURICH RAMUS DISTRACTOR
KLS-MARTIN L.P. 510(k) NO: K983809(TRADITIONAL)
ATTN: ED RANSOM PHONE NO : 813-376-4154
3234 ELLA LANE SE DECISION MADE: 26-JAN-99
NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS
LABTICIAN OPHTHALMICS, INC. 510(k) NO: K983607(TRADITIONAL)
ATTN: R. DAVID SCULATI PHONE NO : 905 829 0055
2140 WINSTON PARK DR., UNIT 6 SE DECISION MADE: 08-JAN-99
OAKVILLE, ONTARIO, CANADA L6H 5V5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTAXIS NASAL PACKING
LES LABORATORIRES BROTHIER, S.A. 510(k) NO: K984069(TRADITIONAL)
ATTN: EVAN DICK PHONE NO : 314-721-0112
7527 WESTMORELAND AVENUE SE DECISION MADE: 25-JAN-99
ST LOUIS, MO 63105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIDCO SYSTEM
LIDCO LTD. 510(k) NO: K962918(TRADITIONAL)
ATTN: TOM TSAKERIS PHONE NO : 301-330-2076
16809 BRIARDALE ROAD SE DECISION MADE: 08-JAN-99
ROCKVILLE, MD 20850 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHT AGE EPICARE ALEXANDRITE LASER
LIGHT AGE, INC. 510(k) NO: K983977(TRADITIONAL)
ATTN: SUSAN LAUFER PHONE NO : 732-563-0600
TWO RIVERVIEW DRIVE SE DECISION MADE: 07-JAN-99
SOMERSET, NJ 08873 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOVYTEX SND BHD POWDER-FREE POLYMER COATED LATEX EXAMINATION GLO
LOVYTEX SDN BHD 510(k) NO: K984147(TRADITIONAL)
ATTN: M.G. DESAI PHONE NO : 603 352 6711
LOT #8, JALAN SUASA SE DECISION MADE: 20-JAN-99
TELOK PANGLIMA GARANG 510(k) SUMMARY AVAILABLE FROM FDA
SELANGOR, MALAYSIA 42500
DEVICE: MS300
LSI INTERNATIONAL, INC. 510(k) NO: K984021(TRADITIONAL)
ATTN: JAMES C LANE PHONE NO : 913-894-4493
8849 BOND SE DECISION MADE: 28-JAN-99
OVERLAND PARK, KS 66214 510(k) STATEMENT
DEVICE: MS400
LSI INTERNATIONAL, INC. 510(k) NO: K984113(TRADITIONAL)
ATTN: JAMES C LANE PHONE NO : 913-984-4493
8849 BOND SE DECISION MADE: 28-JAN-99
OVERLAND PARK, KS 66214 510(k) STATEMENT
DEVICE: LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVE
M/S MIDLAND LATEX PRODUCTS LTD. 510(k) NO: K982114(TRADITIONAL)
ATTN: ANIL SEGAT PHONE NO : 612-462-3648
915 BLUE GENTIAN ROAD SE DECISION MADE: 21-JAN-99
SUITE #1 510(k) STATEMENT
EAGAN, MN 55121
DEVICE: CAPELLA COCHLEAR EMISSIONS ANALYZER
MADSEN ELECTRONICS, INC. 510(k) NO: K983851(TRADITIONAL)
ATTN: TRACY MILLIER PHONE NO : 612-930-0804
5600 ROWLAND ROAD SE DECISION MADE: 28-JAN-99
MINNETONKA, MN 55343 510(k) STATEMENT
DEVICE: MAXXIM; MAXXIM HD
MAJOR MOBILITY PRODUCTS, INC. 510(k) NO: K984493(TRADITIONAL)
ATTN: SCOTT SCHWEISS PHONE NO : 281-398-5444
18206 MANCE CT. SE DECISION MADE: 08-JAN-99
HOUSTON, TX 77094 510(k) STATEMENT
DEVICE: MANAN SPINAL NEEDLES
MANAN MEDICAL PRODUCTS, INC. 510(k) NO: K983620(TRADITIONAL)
ATTN: MICHAEL PLISHKA PHONE NO : 847-498-3333
2200 CARLSON DR. SE DECISION MADE: 08-JAN-99
NORTHBROOK, IL 60062 510(k) STATEMENT
DEVICE: BASIC, MEDIAN, DOMINANT, AND VARIO
MEDELA INC. 510(k) NO: K983552(ABBREVIATED)
ATTN: STEPHEN D SMITH PHONE NO : 815-363-1166
4610 PRIME PARKWAY SE DECISION MADE: 07-JAN-99
MCHENRY, IL 60050-7005 510(k) STATEMENT
DEVICE: BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES
MEDICOTEST A/S 510(k) NO: K983689(TRADITIONAL)
ATTN: EMALEE G MURPHY PHONE NO : 202-496-7255
1900 K STREET N.W. SE DECISION MADE: 15-JAN-99
WASHINGTON, DC 20006-1108 510(k) STATEMENT
DEVICE: NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
MEDICOTEST, INC. 510(k) NO: K983597(TRADITIONAL)
ATTN: EMALEE G MURPHY PHONE NO : 202-496-7255
1900 K STREET, N.W. SE DECISION MADE: 11-JAN-99
WASHINGTON, DC 20006-1108 510(k) STATEMENT
DEVICE: CLEANCUT
MEDQUEST PRODUCTS, INC. 510(k) NO: K972335(TRADITIONAL)
ATTN: PRATAP S KHANWILKAR PHONE NO : 801-355-6255
825 NORTH, 300 WEST, #N143 SE DECISION MADE: 07-JAN-99
SALT LAKE CITY, UT 84103 510(k) STATEMENT
DEVICE: MEDRAD QUADRATURE CTL ARRAY COIL
MEDRAD, INC. 510(k) NO: K984159(TRADITIONAL)
ATTN: JIM FERGUSON JR PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 12-JAN-99
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDRAD PHASED ARRAY NEUROVASCULAR COIL
MEDRAD, INC. 510(k) NO: K984257(TRADITIONAL)
ATTN: JIM FERGUSON, JR. PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 25-JAN-99
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICA
MEDTRONIC PS MEDICAL 510(k) NO: K983799(TRADITIONAL)
ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546
125 CREMONA DR., SE DECISION MADE: 26-JAN-99
UNIVERSITY BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA
GOLETA, CA 93117
DEVICE: MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
MEDTRONIC, INC. 510(k) NO: K984435()
ATTN: JULIE SHERMAN PHONE NO : 612-514-2876
7000 CENTRAL AVENUE N.E. SE DECISION MADE: 07-JAN-99
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDWORKS VISUALIZATION INSEMINATION CATHETER
MEDWORKS CORP. 510(k) NO: K982630(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 401-728-6799
50 BREWSTER STREET SE DECISION MADE: 14-JAN-99
PAWTUCKET, RI 02860 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOSSOM POWDERED LATEX EXAMINATION GLOVES
MEXPO INTERNATIONAL INC. 510(k) NO: K984040(TRADITIONAL)
ATTN: TIM THAI PHONE NO : 510-293-6800
2671 MCCONE AVENUE SE DECISION MADE: 13-JAN-99
HAYWARD,, CA 94545 510(k) STATEMENT
DEVICE: MICOMED - HALM ZIELKE INSTRUMENTATION
MICOMED GMBH 510(k) NO: K982006(TRADITIONAL)
ATTN: CHARMAINE HENDERSON PHONE NO :
511 CATALINA ROAD SE DECISION MADE: 20-JAN-99
FULLERTON, CA 92835 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURORA
NEUROVENA CORP. 510(k) NO: K972065(TRADITIONAL)
ATTN: JIM SEGERMARK PHONE NO : 612-777-3700
1879 BUERKLE RD. SE DECISION MADE: 27-JAN-99
WHITE BEAR LAKE, MN 55110-5246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K983992(TRADITIONAL)
ATTN: JIMMY WONG PHONE NO : 949-240-5260
33051 CALLE AVIADOR SE DECISION MADE: 26-JAN-99
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF PURESPERM
NIDACON INTERNATIONAL AB 510(k) NO: K984172(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 14-JAN-99
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN
NORTH AMERICAN DRAGER 510(k) NO: K983635(TRADITIONAL)
ATTN: GALE E WINARSKY PHONE NO : 215-721-5400
3135 QUARRY RD. SE DECISION MADE: 11-JAN-99
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC
OCULAR SCIENCES, INC. 510(k) NO: K982947(TRADITIONAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 29-JAN-99
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC
OCULAR SCIENCES, INC. 510(k) NO: K984046(TRADITIONAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 21-JAN-99
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: OLYMPUS HX-20 SERIES LIGATING DEVICE
OLYMPUS CORP OF AMERICA 510(k) NO: K984255(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 516-844-5688
4 NEVADA DRIVE SE DECISION MADE: 12-JAN-99
LAKE SUCCESS, NY 11042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE
OMNI INTL. 510(k) NO: K984064(TRADITIONAL)
ATTN: WILLIAM E PATTON PHONE NO : 330-305-0185
4916 SPRUCE HILL DR. NW SE DECISION MADE: 08-JAN-99
CANTON, OH 44718 510(k) STATEMENT
DEVICE: OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELIN
OMNI INTL. 510(k) NO: K984066(TRADITIONAL)
ATTN: WILLIAM E PATTON PHONE NO : 330-305-0185
4916 SPRUCE HILL DR. NW SE DECISION MADE: 13-JAN-99
CANTON, OH 44718 510(k) STATEMENT
DEVICE: MB/BACT BLOOD CULTURE BOTTLE
ORGANON TEKNIKA CORP. 510(k) NO: K983772(TRADITIONAL)
ATTN: REBECCA A RIVAS PHONE NO : 919-620-2288
100 AKZO AVE. SE DECISION MADE: 13-JAN-99
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT P
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K983674(TRADITIONAL)
ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790
100 INDIGO CREEK DRIVE SE DECISION MADE: 29-JAN-99
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS PHBR SLIDES
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K984288(TRADITIONAL)
ATTN: MARLENE A SHULMAN PHONE NO : 716-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 26-JAN-99
ROCHESTER, NY 14626-5101 510(k) STATEMENT
DEVICE: VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K984303(TRADITIONAL)
ATTN: MARLENE SHULMAN PHONE NO : 716-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 28-JAN-99
ROCHESTER, NY 14626-5101 510(k) STATEMENT
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2,
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K984321(TRADITIONAL)
ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790
100 INDIGO CREEK DR. SE DECISION MADE: 22-JAN-99
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNO
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K990026(TRADITIONAL)
ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790
100 INDIGO CREEK DRIVE SE DECISION MADE: 29-JAN-99
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K990061(TRADITIONAL)
ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790
100 INDIGO CREEK DR. SE DECISION MADE: 25-JAN-99
ROCHESTER, NY 14650-0882 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ODI ULTIMATE COMPRESSION HIP SCREW
ORTHOPEDIC DESIGNS, INC. 510(k) NO: K984331(TRADITIONAL)
ATTN: JEFF GODSTED PHONE NO : 727-343-0338
6971 1ST AVE NORTH SE DECISION MADE: 20-JAN-99
ST. PETERSBURG, FL 33710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORAL-EZE ORAL FLUID COLLECTION SYSTEM
OSBORN LABORATORIES, INC. 510(k) NO: K984361(TRADITIONAL)
ATTN: GILBERT P BOURK III PHONE NO : 913-764-5555
14901 WEST 117 STREET SE DECISION MADE: 13-JAN-99
OLATHE, KS 66062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOCHEK SAMPLE COLLECTION KIT
OSBORN LABORATORY 510(k) NO: K984529(TRADITIONAL)
ATTN: GILBERT P BOURKE III PHONE NO : 913-390-7146
14901 WEST 117TH STREET SE DECISION MADE: 28-JAN-99
OLATHE, KS 66062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIFINE
OWEN MUMFORD, INC. 510(k) NO: K983994(TRADITIONAL)
ATTN: ROBERT SHAW PHONE NO : 770-425-5138
849 PICKENS INDUSTRIAL DRIVE SE DECISION MADE: 08-JAN-99
SUITE 14 510(k) SUMMARY AVAILABLE FROM FDA
MARIETTA, GA 30062
DEVICE: DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
OXOID, LTD. 510(k) NO: K982634(TRADITIONAL)
ATTN: ANDY HOLLINGSWORTH PHONE NO : 44 125 6841144
WADE RD. SE DECISION MADE: 28-JAN-99
BASINGSTOKE, HAMPSHIRE, UNITED KIN510(k) STATEMENT
DEVICE: NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
OXOID, LTD. 510(k) NO: K984036(TRADITIONAL)
ATTN: ANDY HOLLINGSWORTH PHONE NO : 012 568 41144
WADE RD. SE DECISION MADE: 13-JAN-99
BASINGSTOKE, HAMPSHIRE, UNITED KIN510(k) STATEMENT
DEVICE: PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM
PACEART, INC. 510(k) NO: K982090(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SOUTH SE DECISION MADE: 26-JAN-99
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND
PALL MEDICAL 510(k) NO: K983735(TRADITIONAL)
ATTN: ROBERT A DICKSTEIN PHONE NO : 516-484-5400
2200 NORTHERN BOULEVARD SE DECISION MADE: 07-JAN-99
EAST HILLS, NY 510(k) STATEMENT
DEVICE: NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOW
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K984356(TRADITIONAL)
ATTN: BOB CHAN PHONE NO : 603 391 1949
42100 KLANG, SE DECISION MADE: 08-JAN-99
P.O. BOX 188, 41720 KLANG 510(k) STATEMENT
SELANGOR, DARUL EHSAN, MALAYSIA 42100
DEVICE: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORE
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K984605(TRADITIONAL)
ATTN: TAN KONG CHANG PHONE NO : 603 391 1949
LOT 754, JALAN HAJI SIRAT SE DECISION MADE: 25-JAN-99
OFF JALAN KAPAR, KLANG 510(k) STATEMENT
SELANGOR, DARUL EHSAN, MALAYSIA 42100
DEVICE: PHILIPS EASYGUIDE
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K981480(TRADITIONAL)
ATTN: FRANK GIANELLI PHONE NO : 203-926-7729
710 BRIDGEPORT AVENUE SE DECISION MADE: 28-JAN-99
P.O. BOX 860 510(k) SUMMARY AVAILABLE FROM FDA
SHELTON, CT 06484-4708
DEVICE: PLANMECA INTRACAM STATION
PLANMECA OY 510(k) NO: K984013(TRADITIONAL)
ATTN: LARS MORING PHONE NO : 358 975 905500
ASENTAJANKATU 6 SE DECISION MADE: 26-JAN-99
HELSINKI, FINLAND 00810 510(k) STATEMENT
DEVICE: CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AN
PRECISION BIOLOGICALS, INC. 510(k) NO: K981173(TRADITIONAL)
ATTN: SANDY MORRISON PHONE NO : 902 468 6422
900 WINDMILL RD., SUITE 100 SE DECISION MADE: 13-JAN-99
DARTMOUTH, N.S., CANADA B3B 1P7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AN
PRECISION BIOLOGICALS, INC. 510(k) NO: K981174(TRADITIONAL)
ATTN: SANDY MORRISON PHONE NO : 902 468 6422
900 WINDMILL RD., SUITE 100 SE DECISION MADE: 13-JAN-99
DARTMOUTH, N.S., CANADA B3B 1P7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
PRECISION BIOLOGICALS, INC. 510(k) NO: K982062(TRADITIONAL)
ATTN: SANDY MORRISON PHONE NO : 902 468 6422
900 WINDMILL RD., SUITE 100 SE DECISION MADE: 13-JAN-99
DARTMOUTH, N.S., CANADA B3B 1P7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACETAL DENTAL/PREFORMED CLASP
PRESSING NORTH AMERICA, INC. 510(k) NO: K983558(TRADITIONAL)
ATTN: MARTIN A RIGUTTO PHONE NO : 888-340-2373
4311 S.W. RESEARCH WAY SE DECISION MADE: 07-JAN-99
CORVALLIS, OR 97333 510(k) STATEMENT
DEVICE: PROTECH PLUS
PROTECH, INC. 510(k) NO: K983547(TRADITIONAL)
ATTN: BARRY BLOCH PHONE NO : 561-241-0400
6421 CONGRESS AVENUE, #102 SE DECISION MADE: 07-JAN-99
BOCA RATON, FL 33487 510(k) STATEMENT
DEVICE: SERAQUEST CMV IGM
QUEST INTL., INC. 510(k) NO: K982485(TRADITIONAL)
ATTN: ROBERT A CORT PHONE NO : 305-948-8788
1938 N.E. 148TH TERR. SE DECISION MADE: 13-JAN-99
NORTH MIAMI, FL 33181 510(k) STATEMENT
DEVICE: STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND
R. THOMAS GROTZ, M.D. INC. 510(k) NO: K984200(TRADITIONAL)
ATTN: R. THOMAS GROTZ PHONE NO : 415-398-2332
530 BUSH STREET, 10TH FLOOR SE DECISION MADE: 21-JAN-99
SAN FRANCISCO, CA 94108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
RADIOMETER AMERICA, INC. 510(k) NO: K982928(TRADITIONAL)
ATTN: VINCE SIGMUND PHONE NO : 440-871-8900
810 SHARON DR. SE DECISION MADE: 06-JAN-99
WESTLAKE, OH 44145-1598 510(k) STATEMENT
DEVICE: RDI DIRECT LDL CHOLESTEROL TEST
REFERENCE DIAGNOSTICS, INC. 510(k) NO: K984107(TRADITIONAL)
ATTN: JOSEPH LAWLOR PHONE NO : 781-276-9000
23 CROSBY DR. SE DECISION MADE: 28-JAN-99
BEDFORD, MA 01730-1401 510(k) STATEMENT
DEVICE: LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY
RIM-WIDE COMPANIES, INC. 510(k) NO: K982115(TRADITIONAL)
ATTN: DANIEL HSU PHONE NO : 619-622-9956
P O BOX 910184 SE DECISION MADE: 13-JAN-99
SAN DIEGO, CA 92191-0184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LC MICROHYBRID
S & C POLYMER GMBH 510(k) NO: K984484(TRADITIONAL)
ATTN: JURGEN ENGELBRECHT PHONE NO : 494 121 8619
ROBERT-BOSCH-STR. 5 SE DECISION MADE: 20-JAN-99
D-25335 510(k) SUMMARY AVAILABLE FROM FDA
ELMSHORN, GERMANY
DEVICE: INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000
SANDHILL SCIENTIFIC, INC. 510(k) NO: K984444(SPECIAL)
ATTN: LINDA L DIEDERICH PHONE NO : 303-470-7020
8955 SOUTH RIDGELINE BLVD., SE DECISION MADE: 11-JAN-99
UNIT #500 510(k) SUMMARY AVAILABLE FROM FDA
HIGHLANDS RANCH, CO 80126
DEVICE: FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS
SCHNEIDER (EUROPE) GMBH 510(k) NO: K984068(TRADITIONAL)
ATTN: THOMAS THALER PHONE NO : 411-872-1171
ACKERSTRASSE 6 SE DECISION MADE: 07-JAN-99
BULACH, SWITZERLAND CH-8180 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATIM 5000 CASSETTE AUTOCLAVE
SCICAN 510(k) NO: K983679(SPECIAL)
ATTN: BRENDA MURPHY PHONE NO : 416 445 1600
1440 DON MILLS RD. SE DECISION MADE: 04-JAN-99
TORONTO, ONTARIO, CANADA M3B 3P9 510(k) STATEMENT
DEVICE: TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEI
SHEN WEI (USA), INC. 510(k) NO: K983145(TRADITIONAL)
ATTN: BELLE L CHOU PHONE NO : 510-429-8690
2845 WHIPPLE RD. SE DECISION MADE: 26-JAN-99
UNION CITY, CA 94587 510(k) STATEMENT
DEVICE: CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS
SIMS DELTEC, INC. 510(k) NO: K984055(TRADITIONAL)
ATTN: LISA STONE PHONE NO : 651-628-7224
1265 GREY FOX RD. SE DECISION MADE: 29-JAN-99
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES
SIMS PORTEX, INC. 510(k) NO: K983858(TRADITIONAL)
ATTN: TIMOTHY J TALCOTT PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 29-JAN-99
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXIKLEEN-LATEX EXAMINATION GLOVE POWDER FREE
SINETIMED LATEX SDN BHD 510(k) NO: K983827(TRADITIONAL)
ATTN: A.S. TAN PHONE NO : 605 891 2777
LOT 118, JALAN LOGAM, 7 SE DECISION MADE: 14-JAN-99
34600 TAIPING 510(k) STATEMENT
PERAK DARUL RIDZUAN, MALAYSIA 34600
DEVICE: NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREE
SINETIMED LATEX SDN BHD 510(k) NO: K983828(TRADITIONAL)
ATTN: A.S. TAN PHONE NO : 605 891 2777
LOT 118, JALAN LOGAM, 7 SE DECISION MADE: 21-JAN-99
34600 TAIPING 510(k) STATEMENT
PERAK DARUL RIDZUAN, MALAYSIA 34600
DEVICE: BIOABSORBABLE INTERFERENCE SCREWS
SMITH & NEPHEW, INC. 510(k) NO: K984320(TRADITIONAL)
ATTN: DEMETRIOS TSAKONAS PHONE NO : 508-261-3600
130 FORBES BLVD. SE DECISION MADE: 28-JAN-99
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
SOFAMOR DANEK USA,INC. 510(k) NO: K981676(TRADITIONAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 28-JAN-99
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S555 INTRAORAL DENTAL CAMERA
SOPRO 510(k) NO: K983625(TRADITIONAL)
ATTN: PIERRE MONTILLOT PHONE NO : 334 912 70727
PLACE ST. CHRISTOPHE SE DECISION MADE: 11-JAN-99
LES ACCATES-LA VALENTINE 510(k) SUMMARY AVAILABLE FROM FDA
MARSEILLE, FRANCE 13011
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES
SRI ANUSHAM RUBBER INDUSTRIES PVT.510(k) NO: K983998(TRADITIONAL)
ATTN: LATHA KUMARASWAMY PHONE NO : 925-734-9868
P.O. BOX 5206 SE DECISION MADE: 21-JAN-99
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERIS TEN SIXTEEN STEAM STERILIZER
STERIS CORP. 510(k) NO: K982332(TRADITIONAL)
ATTN: RAYMOND URSICK PHONE NO : 440-354-2600
5960 HEISELY RD. SE DECISION MADE: 20-JAN-99
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281
STERNGOLD/IMPLAMED 510(k) NO: K984340(ABBREVIATED)
ATTN: GORDON NELSON PHONE NO : 508-226-5660
23 FRANK MOSSBERG DR. SE DECISION MADE: 08-JAN-99
ATTLEBORO, MA 02703-0967 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERNVANTAGE VARNISH LC, MODEL 221001
STERNGOLD/IMPLAMED 510(k) NO: K984341(TRADITIONAL)
ATTN: GORDON NELSON PHONE NO : 508-226-5660
23 FRANK MOSSBERG DR. SE DECISION MADE: 08-JAN-99
ATTLEBORO, MA 02703-0967 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3-CHIP VIDEO CAMERA
STRYKER ENDOSCOPY 510(k) NO: K983566(TRADITIONAL)
ATTN: RICK BEUTTER PHONE NO : 408-567-2123
2590 WALSH AVE. SE DECISION MADE: 11-JAN-99
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHO-COAT ULTRASOUND NEEDLES
STS BIOPOLYMERS 510(k) NO: K983647(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 20-JAN-99
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: WORLD CLASS WHEELED CHAIR, MODEL SS
SUITER MEDICAL L.L.C. 510(k) NO: K984457(TRADITIONAL)
ATTN: JAMES P SUITER PHONE NO : 800-354-3450
203 WEST 2ND STREET SE DECISION MADE: 19-JAN-99
MC COOK, NE 69001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS
SULZER ORTHOPEDICS, INC. 510(k) NO: K983592(TRADITIONAL)
ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202
9900 SPECTRUM DR. SE DECISION MADE: 28-JAN-99
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEALTHSTATION SYSTEM
SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K983670(TRADITIONAL)
ATTN: ROGER WHITE PHONE NO : 303-439-9709
530 COMPTON ST. SE DECISION MADE: 14-JAN-99
BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K984000(TRADITIONAL)
ATTN: ROGER N WHITE PHONE NO : 303-439-9709
530 COMPTON STREET SE DECISION MADE: 12-JAN-99
BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIRSTSAVE BIPHASIC MODELS 9200 AND 9210
SURVIVALINK CORP. 510(k) NO: K982264(TRADITIONAL)
ATTN: SEW-WAH TAY PHONE NO : 612-939-4181
5420 FELTL RD. SE DECISION MADE: 25-JAN-99
MINNEAPOLIS, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENLIGHT-2
SYBRON DENTAL SPECIALITIES, INC. 510(k) NO: K984217(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 20-JAN-99
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENLIGHT LV
SYBRON DENTAL SPECIALITIES, INC. 510(k) NO: K984362(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 21-JAN-99
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE
SYNTEC-TAICHUNG MEDICAL INSTRUMENT510(k) NO: K983988(TRADITIONAL)
ATTN: TED Y SHI PHONE NO : 886 479 87099
2, KUNG SAN ROAD, CHAUN SHING SE DECISION MADE: 27-JAN-99
INDUSTRIAL ZONE, SHEN KANG 510(k) SUMMARY AVAILABLE FROM FDA
CHANG HUA, CHINA (TAIWAN) 509
DEVICE: SYNTHES PROXIMAL TIBIA PLATING SYSTEM
SYNTHES (USA) 510(k) NO: K983787(TRADITIONAL)
ATTN: ANGELA J SILVESTRI PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 21-JAN-99
POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES SPINE CERVIFIX SYSTEM
SYNTHES (USA) 510(k) NO: K984377(TRADITIONAL)
ATTN: JONATHAN M GILBERT PHONE NO : 610-647-9700
P.O. BOX 0548 SE DECISION MADE: 21-JAN-99
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA
DEVICE: SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM
SYNTHES SPINE 510(k) NO: K984612(SPECIAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
P.O. BOX 0548 SE DECISION MADE: 19-JAN-99
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: MODIFICATION OF EMIT D.A.U. OPIATES ASSAY
SYVA CO. 510(k) NO: K984232(TRADITIONAL)
ATTN: PAUL L ROGERS PHONE NO : 408-239-2309
3403 YERBA BUENA ROAD SE DECISION MADE: 22-JAN-99
SAN JOSE, CA 95161-9013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TELEX TINNITUS-COMPANION
TELEX COMMUNICATIONS, INC. 510(k) NO: K984243(TRADITIONAL)
ATTN: TOM SCHELLER PHONE NO : 612-884-4051
9600 ALDRICH AVENUE SOUTH SE DECISION MADE: 21-JAN-99
MINNEAPOLIS, MN 55420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSIFLEX POWDERFREE SURGEON'S GLOVE
TERANG NUSA SDN BHD 510(k) NO: K982957(TRADITIONAL)
ATTN: CHIN GUAN LOW PHONE NO : 609 773 5133
LOT E4 (4), JALAN LAPAN SE DECISION MADE: 13-JAN-99
PENGKALAN CHEPA 2 IND. ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
KOTA BHARU, KELANTAN, MALAYSIA 16100
DEVICE: GT LEGGIERO
TERUMO MEDICAL CORP. 510(k) NO: K981359(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 410-392-7213
125 BLUE BALL RD. SE DECISION MADE: 27-JAN-99
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH
TERUMO MEDICAL CORP. 510(k) NO: K984260(SPECIAL)
ATTN: YUK-TING LEWIS PHONE NO : 410-392-7231
125 BLUE BALL RD. SE DECISION MADE: 26-JAN-99
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POSI-STOP/POSI-TRAC SYSTEM
THE DENTAL MEDICAL DEVICE CO., L.L510(k) NO: K981997(TRADITIONAL)
ATTN: MARCI BLOOM PHONE NO : 973-257-0500
39 AYNSLEY CT. SE DECISION MADE: 12-JAN-99
MONTVILLE, NJ 07045 510(k) STATEMENT
DEVICE: PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EA
TINNITUS TREATMENT CENTERS, INC. 510(k) NO: K982432(TRADITIONAL)
ATTN: DAVID W HOLMES PHONE NO : 800-871-4327
8215 WESTCHESTER, SUITE 150 SE DECISION MADE: 25-JAN-99
DALLAS, TX 75225 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001
TPC ADVANCED TECHNOLOGY, INC. 510(k) NO: K983029(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 619-451-0642
18140 SMOKESIGNAL DRIVE SE DECISION MADE: 29-JAN-99
SAN DIEGO, CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINYL EXAMINATION GLOVES, PREPOWDERED USP
TRANS ANCIENT PRODUCTS CO., LTD. 510(k) NO: K984094(TRADITIONAL)
ATTN: JOANNA LEE PHONE NO : 886 623 35244
SE DECISION MADE: 14-JAN-99
510(k) STATEMENT
DEVICE: TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER
TRUDELL MEDICAL 510(k) NO: K982181(TRADITIONAL)
ATTN: DARRYL FISCHER PHONE NO : 519 455 7060X2205
725 THIRD STREET SE DECISION MADE: 08-JAN-99
LONDON, ONTARIO, CANADA N5V 5G4 510(k) STATEMENT
DEVICE: FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD
TZ MEDICAL, INC. 510(k) NO: K982228(TRADITIONAL)
ATTN: BYRON ZAHLER PHONE NO : 503-639-0282
15858 S.W. UPPER BOONES FERRY SE DECISION MADE: 14-JAN-99
RD. 510(k) STATEMENT
LAKE OSWEGO, OR 97035
DEVICE: UNIK TONGUE CLEANER
UNIK PRODUCTS, INC. 510(k) NO: K983683(TRADITIONAL)
ATTN: HARRY E WERNER PHONE NO : 716-849-1333
SALIBURY & CAMBRIA LLP SE DECISION MADE: 14-JAN-99
42 DELAWARE AVENUE, SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
BUFFALO, NY 14202
DEVICE: MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE
UNITED STATES SURGICAL CORP. 510(k) NO: K984438(TRADITIONAL)
ATTN: CHRISTOPHER A GRAHAM PHONE NO : 203-845-1390
150 GLOVER AVE. SE DECISION MADE: 07-JAN-99
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BISURE LAPAROSCOPIC BIPOLAR FORCEPS
VALLEYLAB, INC. 510(k) NO: K983743(TRADITIONAL)
ATTN: JACK ROGERS PHONE NO : 303-530-6172
5920 LONGBOW DR. SE DECISION MADE: 21-JAN-99
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AZTECH 70
VILLA SISTEMI MEDICALI S.P.A. 510(k) NO: K984524(SPECIAL)
ATTN: AL SOSA PHONE NO : 847-459-3889
1401 WALNUT STREET SE DECISION MADE: 14-JAN-99
SUITE 565 510(k) SUMMARY AVAILABLE FROM FDA
BOULDER, CO 80302
DEVICE: VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WI
VISTAKON 510(k) NO: K983912(TRADITIONAL)
ATTN: SHARON A BRIGGS PHONE NO : 904-443-1471
DV.JOHNSON&JOHNSON VISION PROD SE DECISION MADE: 26-JAN-99
4500 SALISBURY RD. 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32216
DEVICE: VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.)
VYGON CORP. 510(k) NO: K983544(TRADITIONAL)
ATTN: ANNEMARIE CESARIO PHONE NO : 973-227-1830
1129 BLOOMFIELD AVE. SE DECISION MADE: 13-JAN-99
WEST CALDWELL, NJ 07006 510(k) STATEMENT
DEVICE: WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR
WAKO CHEMICALS, USA, INC. 510(k) NO: K984119(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 15-JAN-99
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR
WAKO CHEMICALS, USA, INC. 510(k) NO: K984122(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 20-JAN-99
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO L-TYPE AMYLASE
WAKO CHEMICALS, USA, INC. 510(k) NO: K984184(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 13-JAN-99
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIRCOLL BALLOON DISSECTOR
WELLS JOHNSON CO. 510(k) NO: K984448(TRADITIONAL)
ATTN: KEN RODENBURG PHONE NO : 520-298-6069
8000 SOUTH KOLB RD. SE DECISION MADE: 28-JAN-99
TUCSON, AZ 85706 510(k) STATEMENT
DEVICE: CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CO
WEMBLEY RUBBER PRODUCTS (M) SDN BH510(k) NO: K972615(TRADITIONAL)
ATTN: CHOW YUE WAH PHONE NO : 603 846 1486
LOT 1, JALAN 3, SE DECISION MADE: 26-JAN-99
KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA
SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900
DEVICE: ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONT
WEMBLEY RUBBER PRODUCTS (M) SDN BH510(k) NO: K972616(TRADITIONAL)
ATTN: CHOW YUE WAH PHONE NO : 603 846 1486
LOT 1, JALAN 3, SE DECISION MADE: 27-JAN-99
KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA
SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900
DEVICE: PRECISION UV (VASURFILCON A)
WESLEY-JESSEN 510(k) NO: K982988(TRADITIONAL)
ATTN: JOSEPH FOOS PHONE NO : 847-294-3306
333 E. HOWARD AVENUE SE DECISION MADE: 06-JAN-99
DES PLAINES, IL 60018-5903 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER-DRIVE, WISAP MODEL #7688PD/7688PD1
WISAP GESELLSCHAFT FUR WISSENSCHAF510(k) NO: K982515(TRADITIONAL)
ATTN: HORST SEMM PHONE NO : 081 048 9080
RUDOLF-DIESEL-RING 20 SE DECISION MADE: 19-JAN-99
SAUERLACH, GERMANY D-82054 510(k) STATEMENT
DEVICE: AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608
WISAP GESELLSCHAFT FUR WISSENSCHAF510(k) NO: K982518(TRADITIONAL)
ATTN: HORST SEMM PHONE NO : 081 048 9090
RUDOLF-DIESEL-RING 20 SE DECISION MADE: 14-JAN-99
SAUERLACH, GERMANY D-82054 510(k) STATEMENT
DEVICE: HYS-SURGIFLATOR 150P
WOM GMBH 510(k) NO: K983889(TRADITIONAL)
ATTN: MICHAEL MCGRAIL PHONE NO : 508-337-2188
194 BRANCH ST SE DECISION MADE: 14-JAN-99
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELI
ZEUS SCIENTIFIC, INC. 510(k) NO: K984123(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 11-JAN-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST
ZEUS SCIENTIFIC, INC. 510(k) NO: K984126(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 11-JAN-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYS
ZEUS SCIENTIFIC, INC. 510(k) NO: K984133(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 11-JAN-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYST
ZEUS SCIENTIFIC, INC. 510(k) NO: K984139(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 11-JAN-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TE
ZEUS SCIENTIFIC, INC. 510(k) NO: K984153(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
P.O. BOX 38 SE DECISION MADE: 11-JAN-99
RARITAN, NJ 08869 510(k) STATEMENT
DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TE
ZEUS SCIENTIFIC, INC. 510(k) NO: K984170(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 19-JAN-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYST
ZEUS SCIENTIFIC, INC. 510(k) NO: K984181(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 22-JAN-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TE
ZEUS SCIENTIFIC, INC. 510(k) NO: K984317(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 22-JAN-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM.
ZEUS SCIENTIFIC, INC. 510(k) NO: K984516(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 11-JAN-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
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