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510(k)s Final Decisions Rendered for April 1999 |
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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
Updated 5/5/1999
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