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510(k)s Final Decisions Rendered for January 1999 |
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 CONMED 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
Updated 3/29/2000
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