-
Medical Devices
-
April 1999 510(k) Clearances
Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance.
DEVICE: ALBUMIN BCG, MODEL AL 103-01 A.P. TOTAL CARE, INC. 510(k) NO: K990978(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-335-9277 70 HAWLEY AVE, SE DECISION MADE: 28-APR-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT DEVICE: AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM AAP IMPLANTATE AG 510(k) NO: K990776(TRADITIONAL) ATTN: ELLEN HENKE-KNUPP PHONE NO : 508-747-6098 73 EAGLES NEST ROAD SE DECISION MADE: 29-APR-99 DUXBURY, MA 02332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETEST FOR CEFUROXIME AB BIODISK 510(k) NO: K990722(TRADITIONAL) ATTN: ANNE BOLMSTROM PHONE NO : 468 730 0760 DALVAGEN 10 SE DECISION MADE: 22-APR-99 SOLNA, SWEDEN 16956 510(k) STATEMENT DEVICE: MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15 ADVANCED SPINE FIXATION SYSTEMS, I510(k) NO: K990845(SPECIAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 13-APR-99 IRVINE, CA 92606 510(k) STATEMENT DEVICE: ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT AB AESCULAP, INC. 510(k) NO: K991223(TRADITIONAL) ATTN: STEVE REITZLER PHONE NO : 619-977-1465 13221 MARICOTTE PLACE SE DECISION MADE: 30-APR-99 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONVERTORS SURGICAL GOWNS ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K991034(SPECIAL) ATTN: SHARON ROBBINS PHONE NO : 847-785-3311 1500 WAUKEGAN RD. SE DECISION MADE: 16-APR-99 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE ALLIANCE RUBBER PRODUCTS SDN. BHD.510(k) NO: K990427(TRADITIONAL) ATTN: CHUA HOOI KOON PHONE NO : 600 459 3223559376 LOT 2716&2720, MK 7, KAWASAN SE DECISION MADE: 23-APR-99 PERINDUSTRIAN BUKIT PANCHOR 510(k) STATEMENT NINONG TEBAL, PULAU PINANG, MALAYSIA 14300 DEVICE: NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR ALLIANCE RUBBER PRODUCTS SDN. BHD.510(k) NO: K990485(TRADITIONAL) ATTN: CHUA HOOI KOON PHONE NO : 600 458 32235 PERINDUSTRIAN BUKIT PANCHOR SE DECISION MADE: 23-APR-99 14300 NIBONG TEBAL 510(k) STATEMENT PULAU PINANG, MALAYSIA 52446-U DEVICE: NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR. ALLIANCE RUBBER PRODUCTS SDN. BHD.510(k) NO: K990486(TRADITIONAL) ATTN: CHUA HOOI KOON PHONE NO : 600 459 32235 PERINDUSTRIAN BUKIT PANCHOR SE DECISION MADE: 23-APR-99 14300 NIBONG TEBAL 510(k) STATEMENT PULAU PINANG, MALAYSIA 52446-U DEVICE: ALTHIN MEDICAL AB ALTRACART II ALTHIN MEDICAL AB 510(k) NO: K990010(TRADITIONAL) ATTN: ULF LUNDGREN PHONE NO : 46 457 75900 BOX 39, (FRIDHEMSV. 15) SE DECISION MADE: 15-APR-99 372 21 RONNEBY, SWEDEN 372 21 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD AMBU, INC. 510(k) NO: K982722(TRADITIONAL) ATTN: SANJAY PARIKH PHONE NO : 410-636-1144 611 NORTH HAMMONDS FERRY RD. SE DECISION MADE: 12-APR-99 LINTHICUM, MD 21090-1356 510(k) STATEMENT DEVICE: SHARPS COLLECTION CONTAINER - SAF-T-SHELL AMERICAN MEDICAL MFG., INC. 510(k) NO: K982029(TRADITIONAL) ATTN: MIKE HOFTMAN PHONE NO : 818-701-7171 9410 DESOTO AVE., UNIT J SE DECISION MADE: 06-APR-99 CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVIA PAIN MEDICATION DELIVERY SYSTEM AMTEC MEDICAL, INC. 510(k) NO: K990312(TRADITIONAL) ATTN: TERRELL L FRIEDRICH PHONE NO : 800-221-5293 9119 METRIC BLVD. SE DECISION MADE: 22-APR-99 AUSTIN, TX 78758 510(k) STATEMENT DEVICE: URETERAL ACCESS SHEATH SET APPLIED MEDICAL RESOURCES 510(k) NO: K990775(TRADITIONAL) ATTN: ANIL BHALANI PHONE NO : 949-582-6120 26051 MERIT CIRCLE, #104 SE DECISION MADE: 21-APR-99 LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU ARTHREX, INC. 510(k) NO: K990361(TRADITIONAL) ATTN: VERNON C BROWN PHONE NO : 941-643-5553 2885 SOUTH HORSESHOE DR. SE DECISION MADE: 14-APR-99 NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM AVANTA ORTHOPAEDICS, INC. 510(k) NO: K990596(TRADITIONAL) ATTN: LOUISE M FOCHT PHONE NO : 619-452-8580 9369 CARROLL PARK RD., SUITE A SE DECISION MADE: 29-APR-99 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENU MULTIPLUS MULTI-PURPOSE SOLUTION BAUSCH & LOMB, INC. 510(k) NO: K990422(TRADITIONAL) ATTN: PAUL G STAPLETON PHONE NO : 716-338-8172 1400 NORTH GOODMAN ST. SE DECISION MADE: 27-APR-99 ROCHESTER, NY 14692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER BECTON DICKINSON & CO. 510(k) NO: K984059(TRADITIONAL) ATTN: CHARLES J WELLE PHONE NO : 801-565-2535 9450 SOUTH STATE STREET SE DECISION MADE: 09-APR-99 SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01 BIO-RAD LABORATORIES, INC. 510(k) NO: K990587(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 07-APR-99 IRVINE, CA 92618-2017 510(k) STATEMENT DEVICE: ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10 BIO-RAD LABORATORIES, INC. 510(k) NO: K990610(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO ROAD SE DECISION MADE: 27-APR-99 IRVINE, CA 92618 510(k) STATEMENT DEVICE: MICROPLATE NEONATAL GALT ASSAY BIO-RAD LABORATORIES, INC. 510(k) NO: K990827(SPECIAL) ATTN: JULIET CARRARA PHONE NO : 510-741-6188 4000 ALFRED NOBEL DR. SE DECISION MADE: 09-APR-99 HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 BIO-RAD LABORATORIES, INC. 510(k) NO: K990858(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 21-APR-99 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 7 BIO-RAD LABORATORIES, INC. 510(k) NO: K990888(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO ROAD SE DECISION MADE: 07-APR-99 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 BIO-RAD LABORATORIES, INC. 510(k) NO: K990928(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO ROAD SE DECISION MADE: 16-APR-99 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: O-RING ABUTMENT BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K990277(TRADITIONAL) ATTN: DIANA M EASTON PHONE NO : 205-967-7880 ONE PERINETER PARK SOUTH SE DECISION MADE: 09-APR-99 SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA BIRMINGHAM, AL 35243 DEVICE: SINGLE AXLE TOTAL ELBOW BIOMET, INC. 510(k) NO: K983036(TRADITIONAL) ATTN: FRED MCCLURE PHONE NO : 219-372-1568 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 30-APR-99 WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROVIDENCE CUP SYSTEM BIOPRO, INC. 510(k) NO: K990821(TRADITIONAL) ATTN: CHERYL WARSINSKE PHONE NO : 810-982-7777 17 17TH STREET SE DECISION MADE: 29-APR-99 PORT HURON, MI 48060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AU6 BIOSOUND ESAOTE, INC. 510(k) NO: K990360(TRADITIONAL) ATTN: COLLEEN HIITLE PHONE NO : 317-849-1793 8000 CASTLEWAY DR. SE DECISION MADE: 30-APR-99 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLEASE 6200 ANAESTHESIA VENTILATOR BLEASE MEDICAL EQUIPMENT LTD. 510(k) NO: K982132(TRADITIONAL) ATTN: FRANCIS X CASEY PHONE NO : 12601 RESEARCH PARKWAY SE DECISION MADE: 15-APR-99 ATT: FRANCIS X CASEY 510(k) STATEMENT ORLANDO, FL 32826 DEVICE: BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE BLEASE MEDICAL EQUIPMENT LTD. 510(k) NO: K982137(TRADITIONAL) ATTN: FRANCIS X CASEY PHONE NO : 12601 RESEARCH PARKWAY SE DECISION MADE: 09-APR-99 ATT: FRANCIS X CASEY 510(k) STATEMENT ORLANDO, FL 32826 DEVICE: COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYS BOEHRINGER MANNHEIM CORP. DBA ROCH510(k) NO: K983892(TRADITIONAL) ATTN: LUANN OCHS PHONE NO : 317-845-2000 9115 HAGUE ROAD SE DECISION MADE: 13-APR-99 INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE) BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K990539(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 343 1007 LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 09-APR-99 BATU BELAH, KLANG 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 42100 DEVICE: BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN) BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K990540(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 343 1007 LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 09-APR-99 BATU BELAH, KLANG 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 42100 DEVICE: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K990541(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 343 1007 LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 09-APR-99 BATU BELAH, KLANG 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 42100 DEVICE: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K990542(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 343 1007 LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 09-APR-99 BATU BELAH, KLANG 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 42100 DEVICE: BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER F BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K990543(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 343 1007 LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 09-APR-99 BATU BELAH, KLANG 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 42100 DEVICE: GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE BROADLINE MEDICAL INDUSTRIES 510(k) NO: K990584(TRADITIONAL) ATTN: ANNA M RAMZA PHONE NO : 1432 SHIRE CIRCLE SE DECISION MADE: 23-APR-99 INVERNESS, IL 60067 510(k) STATEMENT DEVICE: INTERPLANT BURDETTE MEDICAL SYSTEMS, INC. 510(k) NO: K982696(TRADITIONAL) ATTN: EVERETTE C BURDETTE PHONE NO : 217-239-0900 206 N. RANDOLPH STREET SE DECISION MADE: 01-APR-99 SUITE 301 510(k) SUMMARY AVAILABLE FROM FDA CHAMPAIGN, IL 61820 DEVICE: ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, BUSINESS SUPPORT INTL. 510(k) NO: K982365(TRADITIONAL) ATTN: DAGMAR S MASER PHONE NO : 312 042 89591 AMSTEL 320-I SE DECISION MADE: 08-APR-99 AMSTERDAM, NETHERLANDS 1017-AP 510(k) STATEMENT DEVICE: HELIOFORM GOLD-BASED ALLOY C. HAFNER GMBH & CO. 510(k) NO: K990670(TRADITIONAL) ATTN: JOHN F LEMKER PHONE NO : 312-372-1121 THREE FIRST NATIONAL PLAZA SE DECISION MADE: 02-APR-99 70 WEST MADISON ST. SUITE 3300 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60602-4207 DEVICE: CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000 CAMBRIDGE HEART, INC. 510(k) NO: K983102(TRADITIONAL) ATTN: JOHN D GREENBAUM PHONE NO : 954-680-2548 20310 SW 48TH ST. SE DECISION MADE: 12-APR-99 FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORI CANTOR & SILVER LTD. 510(k) NO: K990757(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 21-APR-99 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS CAPITAL MARKETING TECHNOLOGIES, IN510(k) NO: K984213(TRADITIONAL) ATTN: JOHN SNYDER PHONE NO : 800-887-3370 3630 SOUTH I 35, SUITE A SE DECISION MADE: 14-APR-99 WACO, TX 76706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESIDE CKMB CARESIDE, INC. 510(k) NO: K990434(TRADITIONAL) ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767 6100 BRISTOL PARKWAY SE DECISION MADE: 19-APR-99 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESIDE CK CARESIDE, INC. 510(k) NO: K990439(TRADITIONAL) ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767 6100 BRISTOL PARKWAY SE DECISION MADE: 19-APR-99 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471 CITIZEN WATCH CO., LTD. 510(k) NO: K984223(SPECIAL) ATTN: JOSEPH D EDMONDSON JR PHONE NO : 202-672-5354 3000 K STREET, N.W., SUITE 500 SE DECISION MADE: 28-APR-99 WASHINGTON, DC 20007 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EEG ELECTRODES MODEL "445 SERIES" CLASS A ENT. 510(k) NO: K982053(TRADITIONAL) ATTN: JANICE A AUDI PHONE NO : 760-365-9121 7607 LUCERNE VISTA SE DECISION MADE: 20-APR-99 YUCCA VALLEY, CA 92284 510(k) STATEMENT DEVICE: CODAN CHEMOSPIKE CODAN US CORP. 510(k) NO: K990711(TRADITIONAL) ATTN: FERGIE FERGUSON PHONE NO : 800-332-6326 3511 WEST SUNFLOWER AVE. SE DECISION MADE: 13-APR-99 SANTA ANA, CA 92704-6944 510(k) STATEMENT DEVICE: AUTOSTAT II ANTI-SM/RNP ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K990624(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 441 314 457111 PENTLANDS SCIENCE PARK SE DECISION MADE: 28-APR-99 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: AUTOSTAT II ANTI-SM ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K990625(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 441 314 457111 PENTLANDS SCIENCE PARK SE DECISION MADE: 28-APR-99 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: AUTOSTAT II ANTI-SS-B/LA ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K990626(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 441 314 457111 PENTLANDS SCIENCE PARK SE DECISION MADE: 28-APR-99 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: AUTOSTAT II ANTI-SS-A/RO ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K990627(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 441 314 457111 PENTLANDS SCIENCE PARK SE DECISION MADE: 28-APR-99 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)EL COGENT DIAGNOTICS LTD. 510(k) NO: K990796(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 714-933-3000 PENTLANDS SCIENCE PARK SE DECISION MADE: 28-APR-99 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: AUTOSTAT II ANTI-SCL-70 ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K990797(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 44 131 4457111 PENTLANDS SCIENCE PARK SE DECISION MADE: 28-APR-99 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL W COHERENT, INC. 510(k) NO: K990947(TRADITIONAL) ATTN: MICHELLE DEETON PHONE NO : 408-764-3601 2400 CONDENSA ST. SE DECISION MADE: 27-APR-99 SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOCUS PILOT CONTOURING WORKSTATION COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K981535(TRADITIONAL) ATTN: MICHAEL A PARSONS PHONE NO : 314-993-0003 1195 CORPORATE LAKE DR. SE DECISION MADE: 02-APR-99 ST. LOUIS, MO 63132-1716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXYCON LENS CON-CISE CONTACT LENS CO. 510(k) NO: K990895(TRADITIONAL) ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000 2000 M STREET NW, SUITE 700 SE DECISION MADE: 14-APR-99 WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENVY GUIDING CATHETER COOK, INC. 510(k) NO: K990726(SPECIAL) ATTN: APRIL LAVENDER PHONE NO : 812-339-2235 925 SOUTH CURRY PIKE SE DECISION MADE: 02-APR-99 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY CORDIS CORP. 510(k) NO: K990631(TRADITIONAL) ATTN: CHARLES J RYAN PHONE NO : 908-412-7446 40 TECHNOLOGY DRIVE SE DECISION MADE: 30-APR-99 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-ST COULTER CORP. 510(k) NO: K990172(TRADITIONAL) ATTN: MARION S GAIDE PHONE NO : 305-380-4331 11800 SW 147 AVENUE SE DECISION MADE: 13-APR-99 MIAMI, FL 33169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS COULTER CORP. 510(k) NO: K990327(TRADITIONAL) ATTN: MARION S GAIDE PHONE NO : 305-380-2594 11800 SW 147 AVENUE SE DECISION MADE: 26-APR-99 MIAMI, FL 33169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COULTER AC T DIFF 2 ANALYZER COULTER CORP. 510(k) NO: K990352(TRADITIONAL) ATTN: THOMAS J ENGLISH PHONE NO : 305-380-4331 11800 SW 147 AVENUE SE DECISION MADE: 01-APR-99 MIAMI, FL 33169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVISED C-REACTIVE PROTEIN CALIBRATOR DADE BEHRING, INC. 510(k) NO: K990824(TRADITIONAL) ATTN: LORRAINE PIESTRAK PHONE NO : 302-631-6279 P.O. BOX 6101, SE DECISION MADE: 16-APR-99 MAIL STOP 514 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE DADE BEHRING, INC. 510(k) NO: K990825(TRADITIONAL) ATTN: LORRAINE PIESTRAK PHONE NO : 302-631-6279 P.O. BOX 6101 SE DECISION MADE: 16-APR-99 ROUTE 896, GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS DADE MICROSCAN, INC. 510(k) NO: K983711(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 2040 ENTERPRISE BLVD. SE DECISION MADE: 27-APR-99 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAUM NEUROGATE TROCAR DAUM GMBH 510(k) NO: K990782(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 28-APR-99 CROFTON, MD 21114 510(k) STATEMENT DEVICE: SILK SUTURE DAVIS & GECK, INC. 510(k) NO: K982853(TRADITIONAL) ATTN: VANADA JOHNSON PHONE NO : 314-895-4100 444 MCDONNELL BLVD. SE DECISION MADE: 30-APR-99 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRINITY II SINGLE CHAMBER DVT PUMP DELPHI CONSULTING GROUP 510(k) NO: K983680(TRADITIONAL) ATTN: J. HARVEY KNAUSS PHONE NO : 713-723-8169 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 28-APR-99 HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE BAGNOLI-8 EMG SYSTEM DELSYS INC. 510(k) NO: K990356(TRADITIONAL) ATTN: GIANLUCA DE LUCA PHONE NO : 617-326-0599 PO BOX 15734 SE DECISION MADE: 29-APR-99 BOSTON, MA 02215 510(k) STATEMENT DEVICE: SOFT TISSUE SUTURE WASHER DEPUY, INC. 510(k) NO: K991135(TRADITIONAL) ATTN: JANET G JOHNSON PHONE NO : 219-372-7484 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 29-APR-99 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERAPEP DHD HEALTHCARE 510(k) NO: K983467(TRADITIONAL) ATTN: JEAN WALLACE PHONE NO : 315-697-2221 125 RASBACH ST. SE DECISION MADE: 02-APR-99 CANASTOTA, NY 13032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K990754(TRADITIONAL) ATTN: KAREN CALLBECK PHONE NO : 902 566 1396 16 MCCARVILLE STREET SE DECISION MADE: 20-APR-99 WEST ROYALTY INDUSTRIAL PARK 510(k) STATEMENT CHARLOTTETOWN, P.E.I., CANADA C1E 2A6 DEVICE: IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5 DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K990886(SPECIAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 06-APR-99 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K991277(SPECIAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 27-APR-99 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPQ TEST SYSTEM DIASORIN 510(k) NO: K982708(TRADITIONAL) ATTN: JUDITH J SMITH PHONE NO : 301-497-0005 9175 GUIFORD ROAD SE DECISION MADE: 02-APR-99 COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION DICOMIT IMAGING SYSTEMS CORP. 510(k) NO: K990248(TRADITIONAL) ATTN: TERRY CALLAHAN PHONE NO : 905 886 9496 75 EAST BEAVER CREEK RD., #9 SE DECISION MADE: 16-APR-99 RICHMOND HILL, ONTARIO, CANADA L4B510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUMEX IODOFORM PACKING STRIP DUMEX MEDICAL SURGICAL PRODUCTS, L510(k) NO: K990332(TRADITIONAL) ATTN: SHARMINI ATHERAY PHONE NO : 416 299 4003EXT245 104 SHORTING RD. SE DECISION MADE: 14-APR-99 SCARBOROUGH, ONTARIO, CANADA M1S 3510(k) STATEMENT DEVICE: DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 DYNAMIC TECHNOLOGY CORP. 510(k) NO: K982134(TRADITIONAL) ATTN: YAW C YANG PHONE NO : 863-578-9566 SCIENCE-BASED INDUSTRIAL PARK SE DECISION MADE: 14-APR-99 HSINCHU, CHINA (TAIWAN) R.O.C. 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 DYNAMIC TECHNOLOGY CORP. 510(k) NO: K990159(TRADITIONAL) ATTN: YAW C YANG PHONE NO : SCIENCE-BASED INDUSTRIAL PARK SE DECISION MADE: 19-APR-99 HSINCHU, CHINA (TAIWAN) R.O.C. 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXPLUG EAGLE VISION, INC. 510(k) NO: K991130(SPECIAL) ATTN: JIM BARLEY PHONE NO : 949-364-9349 6263 POPLAR AVE., SUITE 650 SE DECISION MADE: 20-APR-99 MEMPHIS, TN 38119 510(k) STATEMENT DEVICE: ELASTYLON POWDER-FREE SURGICAL GLOVE ECI MEDICAL TECHNOLOGIES, INC. 510(k) NO: K984337(TRADITIONAL) ATTN: STEPHEN L THOMPSON PHONE NO : 902 541 1225 2 COOK RD. SE DECISION MADE: 09-APR-99 BRIDGEWATER, NOVA SCOTIA, CANADA B510(k) STATEMENT DEVICE: EBI OMEGA 21 SYSTEM ELECTRO-BIOLOGY, INC. 510(k) NO: K990303(TRADITIONAL) ATTN: JON CAPAROTTA PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 29-APR-99 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI VUECATH ENDOSCOPIC SYSTEN ELECTRO-BIOLOGY, INC. 510(k) NO: K990459(TRADITIONAL) ATTN: JON CAPAROTTA PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 23-APR-99 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF: EBI SPINELINK SYSTEM ELECTRO-BIOLOGY, INC. 510(k) NO: K990999(SPECIAL) ATTN: JONAS WILF PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 14-APR-99 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM ELECTRO-BIOLOGY, INC. 510(k) NO: K991092(SPECIAL) ATTN: JONAS WILF PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 29-APR-99 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REHCOR ELECTROMED CORP. 510(k) NO: K990813(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO 7007 SE DECISION MADE: 12-APR-99 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIEW COM ELECTROMED MEDICAL DEVICES CORP. 510(k) NO: K990759(ABBREVIATED) ATTN: PASCAL M KAUFMANN PHONE NO : 450 491 2100 310 INDUSTRIAL SE DECISION MADE: 15-APR-99 ST-EUSTACHE, CANADA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSITE 3000 SYSTEM ENDOCARDIAL SOLUTIONS, INC. 510(k) NO: K983456(TRADITIONAL) ATTN: ANDREW BALO PHONE NO : 651-523-6924 1350 ENERGY LN., SUITE 110 SE DECISION MADE: 21-APR-99 ST. PAUL, MN 55108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUECHEL-PAPPAS MODULAR SALVAGE STEM ENDOTEC, INC. 510(k) NO: K982418(ABBREVIATED) ATTN: GEORGE MAKRIS PHONE NO : 973-762-0095 20 VALLEY STREET SE DECISION MADE: 29-APR-99 SOUTH ORANGE, NJ 07079 510(k) STATEMENT DEVICE: EMS MOUTH TO MASK RESUSCITATORS ENGINEERED MEDICAL SYSTEMS 510(k) NO: K983919(TRADITIONAL) ATTN: JEFF QUINN PHONE NO : 317-872-5500 8529 ZIONSVILLE RD. SE DECISION MADE: 07-APR-99 INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERICHEK TOTAL CHLORINE TEST KIT ENVIRONMENTAL TEST SYSTEMS, INC. 510(k) NO: K983997(TRADITIONAL) ATTN: BRUCE G PIEKARSKI PHONE NO : 219-262-2060 P.O. BOX 4659 SE DECISION MADE: 02-APR-99 ELKHART, IN 46514-0659 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETE EPIC MEDICAL EQUIPMENT SERVICES IN510(k) NO: K990082(TRADITIONAL) ATTN: JEFFREY SECUNDA PHONE NO : 972-801-9854 1800 10TH ST., SUITE 300 SE DECISION MADE: 09-APR-99 PLANO, TX 75074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAVIT LC ESPE DENTAL AG 510(k) NO: K990982(TRADITIONAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1521395 ESPE PLATZ SE DECISION MADE: 23-APR-99 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE ETHICON ENDO-SURGERY, INC. 510(k) NO: K990028(TRADITIONAL) ATTN: CHUCK TABRI PHONE NO : 513-483-3532 4545 CREEK RD. SE DECISION MADE: 01-APR-99 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUA EVENFLO CO., INC. 510(k) NO: K983776(TRADITIONAL) ATTN: DONALD E SEGAL PHONE NO : 202-887-4055 1333 NEW HAMPSHIRE AVE., N.W. SE DECISION MADE: 26-APR-99 SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20036 DEVICE: S.P.A.R STERILE AMBULATORY RESERVOIR FAULDING PHARMACEUTICAL CO. 510(k) NO: K990091(TRADITIONAL) ATTN: HEIKE MAASER PHONE NO : 908-931-3806 11 COMMERCE DRIVE SE DECISION MADE: 04-APR-99 CRANFORD, NJ 07016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER FERRIS MFG. CORP. 510(k) NO: K990906(TRADITIONAL) ATTN: THEODORE R THORSON PHONE NO : 630-887-9797 16 WEST 300 83RD ST. SE DECISION MADE: 29-APR-99 BURR RIDGE, IL 60521 510(k) STATEMENT DEVICE: ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, FISMA, INC. 510(k) NO: K990174(TRADITIONAL) ATTN: TRACY S BEST PHONE NO : 801-972-0500 3959 WEST 1820 SOUTH SE DECISION MADE: 01-APR-99 SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES FLEXITECH SDN. BHD. 510(k) NO: K990495(TRADITIONAL) ATTN: KENNY H.N. LIEW PHONE NO : 603 392 0188 LOT 5071, BATU 5 1/2, JALAN SE DECISION MADE: 02-APR-99 MERU 510(k) STATEMENT KLANG, SELANGOR, MALAYSIA 41050 DEVICE: PREPOWDERED NITRILE EXAMINATION GLOVES FLEXITECH SDN. BHD. 510(k) NO: K990499(TRADITIONAL) ATTN: KENNY H. N. LIEW PHONE NO : 603 392 0188 LOT 5071, BATU 5 1/2, JALAN SE DECISION MADE: 02-APR-99 MERU 510(k) STATEMENT KLANG, SELANGOR, MALAYSIA 41050 DEVICE: POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM FLEXITECH SDN. BHD. 510(k) NO: K990501(TRADITIONAL) ATTN: TU AH KIM PHONE NO : 603 392 0188 LOT 5071, BATU 5 1/2, JALAN SE DECISION MADE: 02-APR-99 MERU 510(k) STATEMENT KLANG, SELANGOR, MALAYSIA 41050 DEVICE: PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELI FLEXITECH SDN. BHD. 510(k) NO: K990502(TRADITIONAL) ATTN: KENNY H. N. LIEW PHONE NO : 603 392 0118 LOT 5071, BATU 5 1/2, JALAN SE DECISION MADE: 02-APR-99 MERU 510(k) STATEMENT KLANG, SELANGOR, MALAYSIA 41050 DEVICE: SMARTBOND G.A.C. INTL., INC. 510(k) NO: K981036(TRADITIONAL) ATTN: MARK MANNI PHONE NO : 315-582-5700 185 OVAL DR. SE DECISION MADE: 05-APR-99 CENTRAL ISLIP, NY 11722 510(k) STATEMENT DEVICE: COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS GAMBRO HEALTHCARE 510(k) NO: K982413(TRADITIONAL) ATTN: JEFFREY R SHIDEMAN PHONE NO : 612-835-4018 1185 OAK ST. SE DECISION MADE: 21-APR-99 LAKEWOOD, CO 80215-4498 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR GEREONICS, INC. 510(k) NO: K991411(TRADITIONAL) ATTN: GERALD A ROST PHONE NO : 760-731-9003 4650-143 DULIN ROAD SE DECISION MADE: 28-APR-99 FALLBROOK, CA 92028 510(k) STATEMENT DEVICE: GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH GLOBAL HEALTHCARE, INC. 510(k) NO: K990567(TRADITIONAL) ATTN: ALAM AHMED PHONE NO : 770-522-7520 130 BRANTLEY RD. SE DECISION MADE: 05-APR-99 ATLANTA, GA 30350 510(k) STATEMENT DEVICE: GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58 GUIDANT CORP. 510(k) NO: K991032(SPECIAL) ATTN: KOBBY DANKWAH PHONE NO : 408-235-4174 3200 LAKESIDE DR. SE DECISION MADE: 30-APR-99 P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA SANTA CLARA, CA 95052-8167 DEVICE: HI-TORQUE BALANCE TREK GUIDE WIRE GUIDANT CORP. 510(k) NO: K991152(SPECIAL) ATTN: MARGARET ANDERSON PHONE NO : 408-235-3995 3200 LAKESIDE DR. SE DECISION MADE: 29-APR-99 P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA SANTA CLARA, CA 95054-2807 DEVICE: EXTRACORPOREAL BLOOD CIRCUIT HAIDYLENA MEDICAL EGYPT 510(k) NO: K982340(TRADITIONAL) ATTN: SAMEH TAMIM PHONE NO : 002 022 750513 26, MAKRAM EBEID ST. SE DECISION MADE: 30-APR-99 NASR CITY, CAIRO, EGYPT 510(k) STATEMENT DEVICE: SMARTCELL PROCESSING SYSTEM HARVEST TECHNOLOGIES, LLC 510(k) NO: K983022(TRADITIONAL) ATTN: RICHARD LARIVIERE PHONE NO : 781-982-1900 77 ACCORD PARK DR., D-7 SE DECISION MADE: 02-APR-99 NORWELL, MA 02061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRACER HEARTLAND MEDICAL SYSTEMS INC. 510(k) NO: K982617(TRADITIONAL) ATTN: JOHN A HUMPHREY PHONE NO : 805-498-4379 725 PICKFORD CT. SE DECISION MADE: 09-APR-99 NEWBURY PARK, CA 91320 510(k) STATEMENT DEVICE: QUICKDRAW VENOUS CANNULA HEARTPORT, INC. 510(k) NO: K981995(TRADITIONAL) ATTN: MARIANNE C DRENNAN PHONE NO : 650-482-4405 200 CHESAPEAKE DR. SE DECISION MADE: 20-APR-99 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HP M2376A DEVICE LINK SYSTEM HEWLETT-PACKARD CO. 510(k) NO: K984194(TRADITIONAL) ATTN: MIKE HUDON PHONE NO : 978-687-1501 3000 MINUTEMAN RD. SE DECISION MADE: 30-APR-99 ANDOVER, MA 01810-1085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP HEWLETT-PACKARD GMBH 510(k) NO: K990972(SPECIAL) ATTN: EGON PFEIL PHONE NO : 703-114-2243 HERRENBERGER STR. 110-140 SE DECISION MADE: 19-APR-99 BOEBLINGEN, GERMANY 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WOUND DRESSING/ABD PAD, MODEL #10810 HOSPITAL SPECIALTY CO. 510(k) NO: K990861(TRADITIONAL) ATTN: JOHN QUIGLEY PHONE NO : 216-361-1230 7501 CARNEGIE AVENUE SE DECISION MADE: 12-APR-99 CLEVELAND, OH 44103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIDEKICK INFUSION KIT I-FLOW CORP. 510(k) NO: K990425(TRADITIONAL) ATTN: ROBERT J BARD PHONE NO : 949-206-2700 20202 WINDROW DR. SE DECISION MADE: 23-APR-99 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BI-DIRECTIONAL TUNNELER IMPRA, INC. 510(k) NO: K991027(SPECIAL) ATTN: KRISTI M KISTNER PHONE NO : 480-894-9515 1625 WEST 3RD ST SE DECISION MADE: 22-APR-99 P.O. BOX 1740 510(k) SUMMARY AVAILABLE FROM FDA TEMPE, AZ 85280-1740 DEVICE: MODIFICATION TO IMTEC SENDAX MDI IMTEC CORP. 510(k) NO: K990983(SPECIAL) ATTN: M.K. PATTERSON PHONE NO : 580-223-4456 2401 NORTH COMMERCE SE DECISION MADE: 13-APR-99 ARDMORE, OK 73401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA LITE LYME IGG ELISA INOVA DIAGNOSTICS, INC. 510(k) NO: K984222(TRADITIONAL) ATTN: BRYS C MYERS PHONE NO : 619-586-9900 10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 15-APR-99 SAN DIEGO, CA 92131 510(k) STATEMENT DEVICE: QUANTA LITE LYME IGM ELISA INOVA DIAGNOSTICS, INC. 510(k) NO: K984234(TRADITIONAL) ATTN: BRYS C MYERS PHONE NO : 619-586-9900 10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 15-APR-99 SAN DIEGO, CA 92131 510(k) STATEMENT DEVICE: IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CON INSTRUMENTATION LABORATORY CO. 510(k) NO: K990302(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE SE DECISION MADE: 08-APR-99 LEXINGTON, MA 02173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTERNATIONAL TECHNOLOGY CONCEPTS 510(k) NO: K984332(TRADITIONAL) ATTN: AUSTIN BREWIN PHONE NO : 510-547-1211 6114 LASALLE AVE SE DECISION MADE: 29-APR-99 SUITE 330 510(k) SUMMARY AVAILABLE FROM FDA OAKLAND, CA 94611 DEVICE: CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, INTERSURGICAL, INC. 510(k) NO: K983610(TRADITIONAL) ATTN: THOMAS R GUNERMAN PHONE NO : 315-451-2900 417 ELECTRONICS PKWY. SE DECISION MADE: 30-APR-99 LIVERPOOL, NY 13088 510(k) STATEMENT DEVICE: HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE INTL. TECHNIDYNE CORP. 510(k) NO: K990449(TRADITIONAL) ATTN: JOHN CLAY PHONE NO : 732-548-5700 6 OLSEN AVE. SE DECISION MADE: 13-APR-99 EDISON, NJ 08820 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 INTRATHERAPEUTICS, INC. 510(k) NO: K981191(TRADITIONAL) ATTN: AMY PETERSON PHONE NO : 612-697-2076 651 CAMPUS DR. SE DECISION MADE: 07-APR-99 ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1 INTUITIVE SURGICAL, INC. 510(k) NO: K990188(TRADITIONAL) ATTN: JOHN N ZORICH, JR. PHONE NO : 650-237-7195 1340 W. MIDDLEFIELD ROAD SE DECISION MADE: 01-APR-99 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC SERUM SUBSTITUTE (SSS) IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K983579(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 23-APR-99 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K983588(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 26-APR-99 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPS D.SIGN PORCELAIN IVOCLAR NORTH AMERICA, INC. 510(k) NO: K990817(TRADITIONAL) ATTN: PETER P MANCUSO PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 06-APR-99 AMHERST, NY 14228 510(k) STATEMENT DEVICE: BARRIER SURGICAL GOWNS JOHNSON & JOHNSON MEDICAL, DIV. OF510(k) NO: K990395(TRADITIONAL) ATTN: JANE ANN MARTIN PHONE NO : 817-262-4048 2500 EAST ARBROOK BLVD. SE DECISION MADE: 13-APR-99 ARLINGTON, TX 76014-3631 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICKRAY DSX 730 JULIE ALLIANCE 510(k) NO: K990002(TRADITIONAL) ATTN: CLAUDE D BERHOIN PHONE NO : 904-254-5099 1095 MASON AVE SE DECISION MADE: 01-APR-99 DAYTONA BEACH, FL 32117 510(k) STATEMENT DEVICE: DCI ENDOSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K990004(TRADITIONAL) ATTN: KEVIN A KENNAN PHONE NO : 800-421-0837 600 CORPORATE POINTE SE DECISION MADE: 02-APR-99 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 KAY SEE DENTAL MFG. CO. 510(k) NO: K991161(TRADITIONAL) ATTN: CLARK SMITH PHONE NO : 816-842-2817 124 EAST MISSOURI AVE. SE DECISION MADE: 29-APR-99 KANSAS CITY, MO 64106-1294 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COWBOY XV KCI NEW TECHNOLOGIES INC. 510(k) NO: K981311(TRADITIONAL) ATTN: JUDITH HARBOUR PHONE NO : 210-255-4468 8023 VANTAGE DR. SE DECISION MADE: 23-APR-99 SAN ANTONIO, TX 78230-4726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KENSTONE KENDA USA 510(k) NO: K990139(TRADITIONAL) ATTN: LONNIE WELLS PHONE NO : 614-866-9803 7095 AMERICANA PARKWAY SE DECISION MADE: 29-APR-99 PO BOX 0132 510(k) SUMMARY AVAILABLE FROM FDA REYNOLDSBURG, OH 43068-4118 DEVICE: KERAVISION VACUUM RING SYSTEM KERAVISION, INC. 510(k) NO: K984540(ABBREVIATED) ATTN: HOWARD H HOLSTEIN PHONE NO : 202-637-5813 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 28-APR-99 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET LABTICIAN OPHTHALMICS, INC. 510(k) NO: K990224(TRADITIONAL) ATTN: R. DAVID SCULATI PHONE NO : 905 829 0055 2140 WINSTON PARK DR., UNIT 6 SE DECISION MADE: 12-APR-99 OAKVILLE, ONTARIO, CANADA L6H 5V5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS "PEIOLAS LARES RESEARCH, INC. 510(k) NO: K983524(TRADITIONAL) ATTN: THOMAS H LOUISELL PHONE NO : 530-345-1767 295 LOCKHEED AVE. SE DECISION MADE: 01-APR-99 CHICO, CA 95973 510(k) STATEMENT DEVICE: ROTORBLADE LI MEDICAL TECHNOLOGIES, INC. 510(k) NO: K983435(ABBREVIATED) ATTN: RHODEMANN LI PHONE NO : 203-944-2800 4 ARMSTRONG RD. SE DECISION MADE: 29-APR-99 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IN TOUCH DIABETES MANAGEMENT SOFTWARE LIFESCAN, INC. 510(k) NO: K984527(TRADITIONAL) ATTN: LORI CONZEN PHONE NO : 408-942-5606 1000 GIBRALTAR DR. SE DECISION MADE: 29-APR-99 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOPEARL LINVATEC CORP. 510(k) NO: K984171(TRADITIONAL) ATTN: CAROL A WEIDEMAN PHONE NO : 727-399-5334 11311 CONCEPT BLVD. SE DECISION MADE: 29-APR-99 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYSTA LC CURING LIGHT, MODEL LC 2500C/BA LYSTA A/S 510(k) NO: K991138(TRADITIONAL) ATTN: GREGERS LYSTAGER PHONE NO : 454 495 3000 GAMMELGAARDSVEJ 102 SE DECISION MADE: 23-APR-99 FARUM, DENMARK DK-3520 510(k) STATEMENT DEVICE: COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER MALLINCKRODT INC. 510(k) NO: K983830(TRADITIONAL) ATTN: TERESA O'SHEA PHONE NO : 314-654-3944 675 MCDONNELL BLVD. SE DECISION MADE: 16-APR-99 ST. LOUIS, MO 63134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHOTOTHERAPY LAMP MEDELA INC. 510(k) NO: K984589(TRADITIONAL) ATTN: BONNIE A BEAVERS PHONE NO : 202-223-5120 4610 PRIME PARKWAY SE DECISION MADE: 20-APR-99 MCHENRY, IL 60050-7005 510(k) STATEMENT DEVICE: MULTI-CURE COMPOSITE CEMENT MEDENTAL INTL. 510(k) NO: K990314(TRADITIONAL) ATTN: DEBRA OLSON PHONE NO : 303-567-2542 1246 CLEAR CREEK RD. SE DECISION MADE: 02-APR-99 EVERGREEN, CO 80434 510(k) STATEMENT DEVICE: MEDEX 3000 SERIES SYRINGE INFUSION PUMP MEDEX, INC. 510(k) NO: K982640(TRADITIONAL) ATTN: CATHY CHENETSKI PHONE NO : 800-529-3932 3637 LACON RD. SE DECISION MADE: 06-APR-99 HILLIARD, OH 43026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE- MEDI-JECT CORP. 510(k) NO: K991294(SPECIAL) ATTN: PEGGY L HOLLAND PHONE NO : 612-475-7773 161 CHESHIRE LANE, SUITE 100 SE DECISION MADE: 23-APR-99 MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 MEDICA CORP. 510(k) NO: K990971(TRADITIONAL) ATTN: PHOTIOS MAKRIS PHONE NO : 781-275-4892 14 DEANGELO DR. SE DECISION MADE: 27-APR-99 BEDFORD, MA 01730 510(k) STATEMENT DEVICE: MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, M MEDICAL COMPONENTS, INC. 510(k) NO: K974236(TRADITIONAL) ATTN: JEANNE M CUSH PHONE NO : 215-256-4201 1499 DELP DR. SE DECISION MADE: 15-APR-99 HARLEYSVILLE, PA 19438 510(k) STATEMENT DEVICE: PBN DRAINAGE CATHETER GUIDEWIRES MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K991097(TRADITIONAL) ATTN: KARL SWARTZ PHONE NO : 800-338-0440 3600 S.W. 47TH AVE. SE DECISION MADE: 23-APR-99 GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE BACK SURGICAL GOWN WITH HAND TOWEL MEDICAL STERILIZATION, INC. 510(k) NO: K984422(TRADITIONAL) ATTN: DAVID MORGANSTERN PHONE NO : 516-496-8822 225 UNDERHILL BLVD. SE DECISION MADE: 02-APR-99 SYOSSET, NY 11791 510(k) STATEMENT DEVICE: SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO MEDISON AMERICA, INC. 510(k) NO: K990970(TRADITIONAL) ATTN: BOB LEIKER PHONE NO : 925-201-2166 6616 OWENS DR. SE DECISION MADE: 07-APR-99 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MDILOG, MODEL MDC-512 MEDTRAC TECHNOLOGIES, INC. 510(k) NO: K990185(TRADITIONAL) ATTN: LINDA L NELSON PHONE NO : 303-985-0252 6950 WEST JEFFERSON AVE., #210 SE DECISION MADE: 01-APR-99 LAKEWOOD, CO 80235 510(k) STATEMENT DEVICE: MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805- MEDTRONIC PS MEDICAL 510(k) NO: K990333(TRADITIONAL) ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546 125 CREMONA DR., SE DECISION MADE: 28-APR-99 UNIVERSITY BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA GOLETA, CA 93117 DEVICE: MEGA 4 MEGA MOTION, INC. 510(k) NO: K982144(TRADITIONAL) ATTN: PAUL GRONKA PHONE NO : 888-415-1200 P.O. BOX 3744 SE DECISION MADE: 14-APR-99 SCRANTON, PA 18505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEGA 3 MEGA MOTION, INC. 510(k) NO: K982145(TRADITIONAL) ATTN: PAUL GRONKA PHONE NO : 888-415-1200 P.O. BOX 3744 SE DECISION MADE: 14-APR-99 SCRANTON, PA 18505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER MIDMARK CORP. 510(k) NO: K990189(TRADITIONAL) ATTN: JAMES RILE PHONE NO : 937-526-8797 60 VISTA DR. SE DECISION MADE: 19-APR-99 VERSAILLES, OH 45380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP MILL POND, INC. 510(k) NO: K984151(TRADITIONAL) ATTN: GREGORY E SANCOFF PHONE NO : 603-896-9090 ONE STILES ROAD, SUITE 104 SE DECISION MADE: 28-APR-99 SALEM, NH 03079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH MILLS BIOPHARMACEUTICALS, INC. 510(k) NO: K984446(TRADITIONAL) ATTN: STANLEY L MILLS PHONE NO : 405-525-3141 120 N.E. 26TH STREET SE DECISION MADE: 16-APR-99 OKLAHOMA CITY, OK 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POINT SETTER MITAKA USA, INC. 510(k) NO: K984355(TRADITIONAL) ATTN: MAX STURGIS PHONE NO : 888-244-6173 2337 LUCKY JOHN DRIVE SE DECISION MADE: 01-APR-99 PARK CITY, UT 84060 510(k) STATEMENT DEVICE: SECOND WIND AIR PURIFIER MONAGAN ENT., INC. 510(k) NO: K980745(TRADITIONAL) ATTN: GERALD C MONAGAN PHONE NO : 716-589-9201 14247 RIDGE RD. SE DECISION MADE: 02-APR-99 ALBION, NY 14411 510(k) STATEMENT DEVICE: TRX-CG POWER TILT AND RECLINE SYSTEM MOTION CONCEPTS 510(k) NO: K990544(TRADITIONAL) ATTN: ALLAN BOYD PHONE NO : 416 751 0400 101 BARTLEY DRIVE SE DECISION MADE: 08-APR-99 TORONTO, ONTARIO, CANADA M4A 1C9 510(k) STATEMENT DEVICE: MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/ MSB,UK 510(k) NO: K990370(TRADITIONAL) ATTN: PHONE NO : BROOKSIDE COTTAGE,RAMSBURY SE DECISION MADE: 12-APR-99 MARLBOROUGH,WILTSHIRE, UNITED KING510(k) STATEMENT DEVICE: NELLCOR PURITAN BENNETT, GOODKNIGHT 418G NELLCOR PURITAN BENNETT FRANCE DVP510(k) NO: K991150(SPECIAL) ATTN: MOUSTAFA ANKI PHONE NO : 333 834 48500 10 ALLEE PELLETIER DOISY SE DECISION MADE: 14-APR-99 VILLERS-LES-NANCY, FRANCE 54600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOLD SCREW NEWDEAL S.A. 510(k) NO: K990622(TRADITIONAL) ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899 9109 COPENHAVER DRIVE SE DECISION MADE: 29-APR-99 POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES NIHON KOHDEN, INC. 510(k) NO: K984504(TRADITIONAL) ATTN: GARY REASONER PHONE NO : 949-250-3959 2601 CAMPUS DR. SE DECISION MADE: 15-APR-99 IRVINE, CA 92612-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORI NIHON KOHDEN, INC. 510(k) NO: K990031(TRADITIONAL) ATTN: GARY REASONER PHONE NO : 714-250-3959 2601 CAMPUS DR. SE DECISION MADE: 16-APR-99 IRVINE, CA 92612-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS NISSEL LTD. 510(k) NO: K990281(TRADITIONAL) ATTN: JOHN M SZABOCSIK PHONE NO : 312-553-0828 203 NORTH WABASH AVENUE SE DECISION MADE: 16-APR-99 SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60601 DEVICE: RSI PROCESS CHALLENGE DEVICE FOR MONITORING STEAM STERILIZATION NORTH AMERICAN SCIENCE ASSOC., INC510(k) NO: K983451(TRADITIONAL) ATTN: MATTHEW SLIVA PHONE NO : 419-666-9455 2261 TRACY RD. SE DECISION MADE: 23-APR-99 NORTHWOOD, OH 43619 510(k) STATEMENT DEVICE: TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, NUCLETRON CORP. 510(k) NO: K983115(TRADITIONAL) ATTN: RALPH SHUPING PHONE NO : 410-312-4100 7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 02-APR-99 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068 NUCLETRON CORP. 510(k) NO: K983337(TRADITIONAL) ATTN: RALPH E SHUPING PHONE NO : 410-312-4100 7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 02-APR-99 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095 NUCLETRON CORP. 510(k) NO: K983338(TRADITIONAL) ATTN: RALPH E SHUPING PHONE NO : 410-312-4100 7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 20-APR-99 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL NUCLETRON CORP. 510(k) NO: K983341(TRADITIONAL) ATTN: RALPH E SHUPING PHONE NO : 410-312-4100 7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 15-APR-99 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLATO BRACHYTHERAPHY, MODEL V. 14.0 NUCLETRON CORP. 510(k) NO: K983343(TRADITIONAL) ATTN: RALPH E SHUPING PHONE NO : 410-312-4100 7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 02-APR-99 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CA O-TWO SYSTEMS INTL., INC. 510(k) NO: K991195(SPECIAL) ATTN: KEVIN BOWDEN PHONE NO : 905 677 9410 7575 KIMBEL ST., UNIT 5 SE DECISION MADE: 22-APR-99 MISSISSAUGA, ONTARIO, CANADA L5S 1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DI-RHEX OPHTHALMIC DIATHERMY SYSTEM OPHTHALMIC TECHNOLOGIES, INC. 510(k) NO: K990064(TRADITIONAL) ATTN: GEORGE MYERS PHONE NO : 201-727-1703 37 KODIAK CRESCENT, SE DECISION MADE: 04-APR-99 UNIT 12 510(k) SUMMARY AVAILABLE FROM FDA DOWNSVIEW, ONTARIO, CANADA MEJ 3E5 DEVICE: DERMACOOL OPTOMED, INC. 510(k) NO: K990417(TRADITIONAL) ATTN: SHAHRIAR GHAFFARI PHONE NO : 512-335-0000 13091 POND SPRINGS RD., #C-250 SE DECISION MADE: 14-APR-99 AUSTIN, TX 78729 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K990984(TRADITIONAL) ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790 100 INDIGO CREEK DR. SE DECISION MADE: 08-APR-99 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMEGA II MODULAR TOTAL HIP SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K984227(TRADITIONAL) ATTN: SAM SON PHONE NO : 410-785-0700 11201 PEPPER RD. SE DECISION MADE: 08-APR-99 HUNT VALLEY, MD 21031-1201 510(k) STATEMENT DEVICE: OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY OSTEONICS CORP. 510(k) NO: K984375(TRADITIONAL) ATTN: MARYBETH NAUGHTON PHONE NO : 201-934-4346 59 ROUTE 17 SE DECISION MADE: 30-APR-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. 510(k) NO: K984513(TRADITIONAL) ATTN: ANDY HOLLINGSWORTH PHONE NO : 44 125 6841144 WADE ROAD SE DECISION MADE: 02-APR-99 RG24 8PW 510(k) STATEMENT BASINGSTOKE,HANTS, UNITED KINGDOM RG24 8PW DEVICE: PVS BASICS PARAGON VISION SCIENCES 510(k) NO: K984436(TRADITIONAL) ATTN: WILLIAM E MEYERS PHONE NO : 602-507-7606 947 EAST IMPALA AVE. SE DECISION MADE: 21-APR-99 MESA, AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICKCARD HCG COMBO TEST, MODEL #9014 PHAMATECH 510(k) NO: K991095(TRADITIONAL) ATTN: CARL MONGIOVI PHONE NO : 619-635-5840 9265 ACTIVITY RD., #112-113 SE DECISION MADE: 28-APR-99 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRX WORLD SHUNT PHOENIX BIOMEDICAL CORP. 510(k) NO: K990256(SPECIAL) ATTN: COURTNEY SMITH PHONE NO : 610-539-9300 2495 GENERAL ARMSTEAD AVE. SE DECISION MADE: 01-APR-99 NORRISTOWN, PA 19403 510(k) STATEMENT DEVICE: BEACON, MODEL 211060 PICKER INTERNATIOANL, INC. 510(k) NO: K983948(TRADITIONAL) ATTN: PHONE NO : 595 MINER ROAD SE DECISION MADE: 16-APR-99 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PILLING WECK SURGICAL Y STENT FORCEPS PILLING WECK, INC. 510(k) NO: K990547(TRADITIONAL) ATTN: JULIE A BEAUMONT PHONE NO : 603-532-7706 1 WECK DRIVE SE DECISION MADE: 27-APR-99 RESEARCH TRIANGLE PARK, NC 27709 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERRY HUMERAL NAIL PIONEER LABORATORIES, INC. 510(k) NO: K990322(TRADITIONAL) ATTN: BURNS SEVERSON PHONE NO : 906-226-9909 375 RIVER PARK CIRCLE SE DECISION MADE: 01-APR-99 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAYFUSE PIONEER LABORATORIES, INC. 510(k) NO: K990804(TRADITIONAL) ATTN: BURNS SEVERSON PHONE NO : 906-226-9909 375 RIVER PARK CIRCLE SE DECISION MADE: 29-APR-99 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZFLOW CONTINUOUS NEBULIZER,MODEL 1005 PIPER MEDICAL PRODUCTS 510(k) NO: K990384(TRADITIONAL) ATTN: SAMUEL DAVID PIPER, PE PHONE NO : 916-375-0112 4007 SEAPORT BLVD. SE DECISION MADE: 26-APR-99 WEST SACRAMENTO, CA 95691 510(k) STATEMENT DEVICE: DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950 POST MEDICAL, INC. 510(k) NO: K990371(TRADITIONAL) ATTN: DAVID R THEAD PHONE NO : 770-928-4100 P.O. BOX 29863 SE DECISION MADE: 21-APR-99 ATLTANTA, GA 30359 510(k) STATEMENT DEVICE: 'ECURLINE UMBILICAL CORD CLAMP #3500 PRECISION DYNAMICS CORP. 510(k) NO: K990737(TRADITIONAL) ATTN: KALYNA SNYLYK PHONE NO : 818-897-1111 13880 DEL SUR ST. SE DECISION MADE: 06-APR-99 SAN FERNANDO, CA 91340-3490 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR PRINCETON BIOMEDITECH CORP. 510(k) NO: K991018(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. ROUTE 1 SE DECISION MADE: 15-APR-99 P.O. BOX 7139 510(k) STATEMENT MONMOUTH JUNCTION, NJ 08852-1905 DEVICE: ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA PRINCETON BIOMEDITECH CORP. 510(k) NO: K991076(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. ROUTE 1 SE DECISION MADE: 15-APR-99 P.O. BOX 7139 510(k) STATEMENT MONMOUTH JUNCTION, NJ 08852-1905 DEVICE: ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOS PRINCETON BIOMEDITECH CORP. 510(k) NO: K991078(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. ROUTE 1 SE DECISION MADE: 15-APR-99 P.O. BOX 7139 510(k) STATEMENT MONMOUTH JUNCTION, NJ 08852-1905 DEVICE: ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO PRINCETON BIOMEDITECH CORP. 510(k) NO: K991079(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. ROUTE 1 SE DECISION MADE: 15-APR-99 P.O. BOX 7139 510(k) STATEMENT MONMOUTH JUNCTION, NJ 08852-1905 DEVICE: ACCUSIGN MTD, BIOSIGN MTD PRINCETON BIOMEDITECH CORP. 510(k) NO: K991080(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. ROUTE 1 SE DECISION MADE: 15-APR-99 P.O. BOX 7139 510(k) STATEMENT MONMOUTH JUNCTION, NJ 08852-1905 DEVICE: ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BA PRINCETON BIOMEDITECH CORP. 510(k) NO: K991082(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. ROUTE 1 SE DECISION MADE: 15-APR-99 P.O. BOX 7139 510(k) STATEMENT MONMOUTH JUNCTION, NJ 08852-1905 DEVICE: ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/M PRINCETON BIOMEDITECH CORP. 510(k) NO: K991084(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. ROUTE 1 SE DECISION MADE: 15-APR-99 P.O. BOX 7139 510(k) STATEMENT MONMOUTH JUNCTION, NJ 08852-1905 DEVICE: LTV 1000 PULMONETIC SYSTEMS, INC. 510(k) NO: K984056(TRADITIONAL) ATTN: DOUGLAS F DEVRIES PHONE NO : 909-783-2280 930 S. MT. VERNON AVE. SE DECISION MADE: 12-APR-99 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA COLTON, CA 92324 DEVICE: QUINTON MEDTRACK CR PLUS TREADMILL QUINTON INSTRUMENT CO. 510(k) NO: K990866(TRADITIONAL) ATTN: MATTHEW J HEDLUND PHONE NO : 425-402-2416 3303 MONTE VILLA PKWY. SE DECISION MADE: 29-APR-99 BOTHELL, WA 98021-8906 510(k) STATEMENT DEVICE: RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER W RADIONICS, INC. 510(k) NO: K980903(TRADITIONAL) ATTN: MICHAEL A ARNOLD, PH.D PHONE NO : 781-272-1233 22 TERRY AVE. SE DECISION MADE: 19-APR-99 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTICAL TRACKING SYSTEM (OTS) RADIONICS, INC. 510(k) NO: K990632(TRADITIONAL) ATTN: LISA MISTERKA BENATI PHONE NO : 781-272-1233 22 TERRY AVE. SE DECISION MADE: 29-APR-99 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REDI-TEST THC REDWOOD BIOTECH INC. 510(k) NO: K990870(TRADITIONAL) ATTN: JANIS FREESTONE PHONE NO : 408-541-8970 520 WEDDELL DRIVE, SUITE 8 SE DECISION MADE: 27-APR-99 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTRECORDER, MODEL 2500 RESPIRONICS, INC. 510(k) NO: K990199(TRADITIONAL) ATTN: BETSY CORTELLONI PHONE NO : 770-429-2894 1255 KENNESTONE CIR. SE DECISION MADE: 19-APR-99 MARIETTA, GA 30066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771, RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K990147(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 16-APR-99 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8 ROCHE DIAGNOSTICS CORP. 510(k) NO: K990399(TRADITIONAL) ATTN: JENNIFER TRIBBETT PHONE NO : 317-845-2000 9115 HAGUE RD. SE DECISION MADE: 15-APR-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) ROCHE DIAGNOSTICS CORP. 510(k) NO: K990409(TRADITIONAL) ATTN: JENNIFER L TRIBBETT PHONE NO : 317-576-3742 9115 HAGUE RD. SE DECISION MADE: 15-APR-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONTRAK TESTCUP-ER M2K ROCHE DIAGNOSTICS CORP. 510(k) NO: K990418(TRADITIONAL) ATTN: JENNIFER L TRIBBETT PHONE NO : 317-576-3742 9115 HAGUE RD. SE DECISION MADE: 13-APR-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 ROCHE DIAGNOSTICS CORP. 510(k) NO: K990594(TRADITIONAL) ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723 9115 HAGUE RD. SE DECISION MADE: 14-APR-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B ROCHE DIAGNOSTICS CORP. 510(k) NO: K990595(TRADITIONAL) ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723 9115 HAGUE RD. SE DECISION MADE: 14-APR-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE ROSS PRODUCTS, DIV. ABBOTT LABORAT510(k) NO: K990863(SPECIAL) ATTN: DANIEL HAMILTON PHONE NO : 614-624-3743 625 CLEVELAND AVENUE SE DECISION MADE: 06-APR-99 COLUMBUS, OH 43215 510(k) STATEMENT DEVICE: BIOMESH BIODEGRADABLE GTR BARRIER SAMYANG CORP. 510(k) NO: K990363(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LANE, SUITE C-100 SE DECISION MADE: 09-APR-99 PLEASANT HILL, CA 94523-3389 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-TIP INTRAOSSEOUS PERFORATOR SCHIFF & CO. 510(k) NO: K990511(TRADITIONAL) ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830 1129 BLOOMFIELD AVE. SE DECISION MADE: 27-APR-99 WEST CALDWELL, NJ 07006 510(k) STATEMENT DEVICE: SPIROVIT, MODEL SP-250 SCHILLER AG 510(k) NO: K984031(TRADITIONAL) ATTN: MARKUS BUETLER PHONE NO : 041 766 4252 ALTGASSE 68 SE DECISION MADE: 30-APR-99 CH-6340 BAAR, SWITZERLAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM SELFCARE, INC. 510(k) NO: K990939(SPECIAL) ATTN: CAROL ADILETTO PHONE NO : 781-647-3900 200 PROSPECT ST. SE DECISION MADE: 20-APR-99 WALTHAM, MA 02154-3457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERIM BLOOD LEAK TEST STRIP SERIM RESEARCH CORP. 510(k) NO: K990206(TRADITIONAL) ATTN: ROBERT J CARRICO PHONE NO : 219-264-3440 23565 REEDY DRIVE SE DECISION MADE: 21-APR-99 P.O. BOX 4002 510(k) SUMMARY AVAILABLE FROM FDA ELKHART, IN 46514 DEVICE: VISION PORCELAIN SERVO DENTAL USA, INC. 510(k) NO: K990790(TRADITIONAL) ATTN: ANGELIKA RINEHART PHONE NO : 847-205-1778 1770 BIRCH RD. SE DECISION MADE: 02-APR-99 NORTHBROOK, IL 60062-5908 510(k) STATEMENT DEVICE: SHEATHES (NON-LATEX), STERILE SHEATHING TECHNOLOGIES, INC. 510(k) NO: K990175(TRADITIONAL) ATTN: LAWRENCE S POLAYES PHONE NO : 408-977-0144 334 COMMERCIAL ST. SE DECISION MADE: 21-APR-99 SAN JOSE, CA 95112 510(k) STATEMENT DEVICE: SHIMADZU CEILING TUBE SUPPORT CH-30GH SHIMADZU CORP. 510(k) NO: K990715(ABBREVIATED) ATTN: MICHAEL FISHBACK PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVENUE SE DECISION MADE: 16-APR-99 TORRANCE, CA 90502-1328 510(k) STATEMENT DEVICE: SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX SHIMADZU MEDICAL SYSTEMS 510(k) NO: K984156(TRADITIONAL) ATTN: MICHAEL FISHBACK PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVE. SE DECISION MADE: 21-APR-99 TORRANCE, CA 90502-1328 510(k) STATEMENT DEVICE: THORAX FD AND MULTIX FD SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K983732(TRADITIONAL) ATTN: MALGORZATA STANEK PHONE NO : 732-321-3950 186 WOOD AVENUE SOUTH SE DECISION MADE: 21-APR-99 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIO-CT MIYABI SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K990491(TRADITIONAL) ATTN: ALICIA BUSTOS-JUERGENSEN PHONE NO : 732-321-3243 186 WOOD AVE. SOUTH SE DECISION MADE: 05-APR-99 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF: DAVIDSTRIP HCG SIMEX MEDICAL, INC. 510(k) NO: K991067(TRADITIONAL) ATTN: MICHELLE J HALL PHONE NO : 206-575-2368 560 INDUSTRY DRIVE SE DECISION MADE: 27-APR-99 SEATTLE, WA 98188 510(k) STATEMENT DEVICE: ORTHOPHOS 3/3 CEPH/3 DS SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K990528(TRADITIONAL) ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 30-APR-99 NORTH ATTLEBORO, MA 02760 510(k) STATEMENT DEVICE: SMITH & NEPHEW HANDPORT SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K990414(TRADITIONAL) ATTN: AMY L WALTERS PHONE NO : 508-261-3776 130 FORBES BLVD. SE DECISION MADE: 14-APR-99 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S575 INTRAORAL DOCKING DENTAL CAMERA SOPRO 510(k) NO: K990948(TRADITIONAL) ATTN: PIERRE MONTILLOT PHONE NO : 334 912 70727 PLACE ST. CHRISTOPHE SE DECISION MADE: 21-APR-99 LES ACCATES-LA VALENTINE 510(k) SUMMARY AVAILABLE FROM FDA MARSEILLE, FRANCE 13011 DEVICE: KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABE SSN GLOVES (M) SDN BHD 510(k) NO: K990526(TRADITIONAL) ATTN: ANG TECK LEONG PHONE NO : 603 441 3488 LOT 147, JALAN SELVADURAI, SE DECISION MADE: 23-APR-99 OFF JALAN IPOH 510(k) STATEMENT KUALA LUMPUR, MALAYSIA 51200 DEVICE: KLEENHANDS POWDERED LATEX EXAMINATION GLOVES SSN GLOVES (M) SDN BHD 510(k) NO: K990527(TRADITIONAL) ATTN: ANG TECK LEONG PHONE NO : 603 441 3488 LOT 147, JALAN SELVADURAI, SE DECISION MADE: 23-APR-99 OFF JALAN IPOH 510(k) STATEMENT KUALA LUMPUR, MALAYSIA 51200 DEVICE: LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM STAR MEDICAL TECHNOLOGIES, INC. 510(k) NO: K982940(TRADITIONAL) ATTN: MARCY MOORE PHONE NO : 919-676-7166 9516 CANDOR OAKS DRIVE SE DECISION MADE: 08-APR-99 RALEIGH, NC 27615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTI STELLAR BIO SYSTEMS, INC. 510(k) NO: K990915(TRADITIONAL) ATTN: JOHN BREWER PHONE NO : 410-381-8550 9075 GUILFORD RD. SE DECISION MADE: 21-APR-99 COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY STELLAR BIO SYSTEMS, INC. 510(k) NO: K990916(TRADITIONAL) ATTN: JOHN BREWER PHONE NO : 410-381-8550 9075 GUILFORD RD. SE DECISION MADE: 21-APR-99 COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRAUMANN EXTRAORAL IMPLANT SYSTEM STRAUMANN USA 510(k) NO: K990458(TRADITIONAL) ATTN: LINDA JALBERT PHONE NO : 800-448-8168 RESERVOIR PLACE, SE DECISION MADE: 16-APR-99 1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA WALTHAM, MA 02154 DEVICE: OMNI-FIX, NAIL SYSTEM SURGICAL IMPLANTS, INC. 510(k) NO: K990307(TRADITIONAL) ATTN: DOUGLAS W STEWART PHONE NO : 941-366-1882 962 SOUTH TAMIAMI TRAIL, #203 SE DECISION MADE: 01-APR-99 SARASOTA, FL 34326 510(k) STATEMENT DEVICE: B2C, ESPACE REVISION CUP SYSTEM SURGICAL IMPLANTS, INC. 510(k) NO: K990523(TRADITIONAL) ATTN: DOUGLAS W STUART PHONE NO : 941-366-1882 962 SOUTH TAMIAMI TRAIL, #203 SE DECISION MADE: 30-APR-99 SARASOTA, FL 34326 510(k) STATEMENT DEVICE: FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K990214(TRADITIONAL) ATTN: ROGER N WHITE PHONE NO : 303-439-9709 530 COMPTON ST. SE DECISION MADE: 22-APR-99 BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRODIGY 4 SYBRON DENTAL SPECIALTIES,INC 510(k) NO: K990898(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 06-APR-99 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT T THERAPY LINK, INC. 510(k) NO: K990129(TRADITIONAL) ATTN: CRAIG SEYL PHONE NO : 913-851-8993 P.O. BOX 192004 SE DECISION MADE: 12-APR-99 LENEXA, KS 66215 510(k) STATEMENT DEVICE: ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX TILLOTSON HEALTHCARE CORP. 510(k) NO: K982505(TRADITIONAL) ATTN: EDWARD MARKOVIC PHONE NO : 800-445-6830 360 ROUTE 101 SE DECISION MADE: 02-APR-99 BEDFORD, NH 03110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHTLY POWDERED LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING TOP GLOVE SDN. BHD. 510(k) NO: K990468(TRADITIONAL) ATTN: LIM WEE CHAI PHONE NO : 603 392 1992/1905 41050 KLANG,SELANGOR SE DECISION MADE: 27-APR-99 DARUL EHSAN, MALAYSIA 510(k) STATEMENT DEVICE: TOP WHOLESOME FACE MASK TOP WHOLESOME ENTERPRISE CO., LTD.510(k) NO: K984389(TRADITIONAL) ATTN: URAI CHAROENSUK PHONE NO : 662 748 7899 A.P. NAKARINTR TOWER 18TH FL SE DECISION MADE: 09-APR-99 333 MOO 9, SRINAKARINTR RD. 510(k) STATEMENT BANGNA, THAILAND 10260 DEVICE: OPART, MODEL MRT-600 TOSHIBA AMERICA MRI, INC. 510(k) NO: K990007(TRADITIONAL) ATTN: KEN NEHMER PHONE NO : 650-872-2722 280 UTAH AVE. SE DECISION MADE: 01-APR-99 SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPART TOSHIBA AMERICA MRI, INC. 510(k) NO: K990260(TRADITIONAL) ATTN: HSU CHANG PHONE NO : 650-827-2722 280 UTAH AVE. SE DECISION MADE: 15-APR-99 SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNI-FLEX RESIN TRANS-ATLANTIC DENTAL 510(k) NO: K983461(TRADITIONAL) ATTN: CAROLINE M ZALESKI PHONE NO : 609-695-0168 46 ARCTIC PKWY. SE DECISION MADE: 13-APR-99 TRENTON, NJ 08638-3041 510(k) STATEMENT DEVICE: ENDOMETRIAL SAMPLER U.A. MEDICAL PRODUCTS, INC. 510(k) NO: K990387(TRADITIONAL) ATTN: FANISH ENGINEER PHONE NO : 704-841-7297 9303-G2 MONROE RD. SE DECISION MADE: 20-APR-99 CHARLOTTE, NC 28270 510(k) STATEMENT DEVICE: CLEARPLAN EASY HOME PREGNANCY TEST UNIPATH LTD. 510(k) NO: K990262(TRADITIONAL) ATTN: LOUISE ROBERTS PHONE NO : 441 234 835564 PRIORY BUSINESS PARK SE DECISION MADE: 07-APR-99 BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT DEVICE: KINGLI ACUPUNCTURE NEEDLE UNITED PACIFIC CO., LTD. 510(k) NO: K990406(TRADITIONAL) ATTN: DANIEL YE HUA PHONE NO : 626-458-8518 219 SOUTH RAYMOND AVE. SE DECISION MADE: 16-APR-99 ALHAMBRA, CA 91801 510(k) STATEMENT DEVICE: MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE UNITED STATES SURGICAL CORP. 510(k) NO: K990951(TRADITIONAL) ATTN: VICTOR M CLAVELLI PHONE NO : 203-845-4543 150 GLOVER AVE. SE DECISION MADE: 01-APR-99 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURE UNITED STATES SURGICAL CORP. 510(k) NO: K990952(TRADITIONAL) ATTN: VICTOR M CLAVELLI PHONE NO : 203-845-4543 150 GLOVER AVE. SE DECISION MADE: 01-APR-99 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PVR-100/VASOGRAM VASOCOR, INC. 510(k) NO: K990123(TRADITIONAL) ATTN: JEFF RAINES PHONE NO : 305-592-7260 7705 N.W. 48TH STREET SE DECISION MADE: 12-APR-99 SUITE 120 510(k) STATEMENT MIAMI, FL 33166 DEVICE: SMARTVENT 201 PORTABLE VENTILATOR VERSAMED LTD. 510(k) NO: K981668(TRADITIONAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 977 18130 117 AHUZAH ST. SE DECISION MADE: 07-APR-99 RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PDQ AND PDQ-TI ABUTMENT VIDENT 510(k) NO: K990367(TRADITIONAL) ATTN: BARBARA J LEWANDOWSKI PHONE NO : 714-961-6200 3150 EAST BIRCH STREET SE DECISION MADE: 21-APR-99 PO BOX 2340 510(k) STATEMENT BREA, CA 92822-2340 DEVICE: VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX VILEX, INC. 510(k) NO: K991151(TRADITIONAL) ATTN: ABRAHIM LAVI PHONE NO : 412-384-7570 1801 RT. 51, BUILDING 10 SE DECISION MADE: 26-APR-99 JEFFERSON HILLS, PA 15025-0724 510(k) STATEMENT DEVICE: VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX VILEX, INC. 510(k) NO: K991197(TRADITIONAL) ATTN: ABRAHIM LAVI PHONE NO : 412-384-7570 1801 RT. 51, BUILDING 10 SE DECISION MADE: 26-APR-99 JEFFERSON HILLS, PA 15025-0724 510(k) STATEMENT DEVICE: STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FR VISUALIZATION TECHNOLOGY, INC. 510(k) NO: K990919(SPECIAL) ATTN: PETER OHANIAN PHONE NO : 978-933-1000 200 RESEARCH DR. SE DECISION MADE: 15-APR-99 WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSEAL CARDIOVASCULAR PATCH W.L. GORE & ASSOC., INC. 510(k) NO: K984526(TRADITIONAL) ATTN: TIMOTHY J RYNN PHONE NO : 800-437-8181 3450 WEST KILTIE LANE SE DECISION MADE: 08-APR-99 P.O. BOX 500 510(k) SUMMARY AVAILABLE FROM FDA FLAGSTAFF, AZ 86002-0500 DEVICE: RAPIDFLAP CRANIAL CLAMP WALTER LORENZ SURGICAL, INC. 510(k) NO: K991029(SPECIAL) ATTN: DIANA PRESTON PHONE NO : 904-741-4400 1520 TRADEPORT DR. SE DECISION MADE: 23-APR-99 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATER TREATMENT SYSTEM FOR HEMODIALYSIS WATER VAULT, INC. 510(k) NO: K983512(TRADITIONAL) ATTN: MICHAEL J PETERSON PHONE NO : 615-292-7336 2003 BLAIR BOULEVARD SE DECISION MADE: 28-APR-99 NASHVILLE, TN 37212 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WILTEK HOT BIOPSY FORCEPS WILTEK MEDICAL, INC. 510(k) NO: K990231(TRADITIONAL) ATTN: JON S WILSON PHONE NO : 910-761-1127 101 NORTH CHESTNUT ST., #300 SE DECISION MADE: 13-APR-99 WINSTON-SALEM, NC 27101 510(k) STATEMENT DEVICE: DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROT WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K991044(TRADITIONAL) ATTN: CHENG HEAN KHOO PHONE NO : 603 846 2055 LOT11, JL.2,KAWASAN PERUSAHAAN SE DECISION MADE: 23-APR-99 BANDAR BARU SLAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA SELANGOR DAURL EHSAN, SEPANG, MALAYSIA 43900 DEVICE: SOF-SUCTION FLUID EVACUATION SYSTEM X-TECH MEDICAL 510(k) NO: K990749(TRADITIONAL) ATTN: EDGAR A RAININ PHONE NO : 925-736-5001 111 WILD OAK COURT SE DECISION MADE: 02-APR-99 DANVILLE, CA 94506 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORLIGHT 2000 SURGICAL LASER SYSTEM YBEAM TECHNOLOGIES, INC. 510(k) NO: K990452(TRADITIONAL) ATTN: JUDY F GORDON PHONE NO : 949-854-6314 18732 SAGINAW SE DECISION MADE: 29-APR-99 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOLTER 2000 ZYMED MEDICAL INSTRUMENTATION 510(k) NO: K990170(SPECIAL) ATTN: GRETEL LUMLEY PHONE NO : 800-235-5941 20 NORTH AVIADOR STREET SE DECISION MADE: 13-APR-99 CAMARILLO, CA 93010 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 262 TOTAL WITH SUMMARIES 163 TOTAL WITH STATEMENTS 99
-
-