FDA 510(k) Decisions During November, 1980  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K802751 11/12/1980 P-10 POSTERIOR FILLING MATERIAL 3M COMPANY
K802669 11/12/1980 CYBREX AMIKACIN ABBOTT LABORATORIES
K802579 11/12/1980 CYBREX TM FPQ FLUORESCENE POLARIZATION ABBOTT LABORATORIES
K802668 11/24/1980 CYBREX TOBRAMYCIN ABBOTT LABORATORIES
K802663 11/12/1980 BLOW-BY-SET-UP CONNECTOR-AIRWAY AIRLIFE, INC.
K802483 11/12/1980 LIGMAJECT ALAN J. KHEDARRI D.D.S., INC.
K802470 11/12/1980 T3 RADIOIMMUNOASSAY KIT AMERICAN DIAGNOSTIC CORP.
K802469 11/12/1980 T4 RADIOIMMUNOASSAY KIT AMERICAN DIAGNOSTIC CORP.
K802670 11/26/1980 CONTIUOUS WAVE DOPPLER ULTRASOUND AMERICAN EDWARDS LABORATORIES
K802761 11/19/1980 LATEX PENROSE TUBING CAT. #20400,414,416 AMERICAN HOSPITAL SUPPLY CORP.
K802384 11/12/1980 CENTRAL VENOUS CATHETER DRESSING TRAY AMERICAN MEDICAL DISPOSABLE, INC.
K802385 11/12/1980 CUSTOM DRESSING TRAY-WET TO DRY/MASS. AMERICAN MEDICAL DISPOSABLE, INC.
K802383 11/12/1980 CUSTOM DRESSING TRAY/CARDINAL CUSHING AMERICAN MEDICAL DISPOSABLE, INC.
K802388 11/12/1980 MAJOR DRESSING TRAY-MILFORD HOSP. AMERICAN MEDICAL DISPOSABLE, INC.
K802387 11/12/1980 MINOR DRESSING TRAY-MILFORD HOSP. AMERICAN MEDICAL DISPOSABLE, INC.
K802386 11/12/1980 SUTURE WOUND TRAY MILFORD WHITTINSVILLE AMERICAN MEDICAL DISPOSABLE, INC.
K802600 11/12/1980 AMP PORTABLE PATIENT PRESSURE MONITOR AMERICAN MEDICAL PRODUCTS, INC.
K802630 11/26/1980 CAFFEINE REAGENT DIAZO COLORIMETRY AMERICAN MONITOR CORP.
K802419 11/12/1980 AO NON-CONTACT II TONOMETER AMERICAN OPTICAL CORP.
K802088 11/28/1980 AUXILIARY TRAY AMERICAN PHARMASEAL DIV. AHSC
K802580 11/12/1980 SUBCLAVIAN CATHETER INSERTION TRAY AMERICAN PHARMASEAL DIV. AHSC
K801974 11/12/1980 ANALYTIC TECH. METAL POINT HEATER #3001 ANALYTIC TECHNOLOGY
K802653 11/24/1980 MEDIUM SIZE OXYGEN HOOD #1547 ANN ARBOR PLASTICS, INC.
K802666 11/26/1980 APTEK ULTRASOUND PROCEDURE TRAY APTEK LTD.
K802588 11/19/1980 MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. ARCO MEDICAL PRODUCTS CO.
K802660 11/24/1980 ANSWER AT-HOME PREGNANCY TEST KIT ARMKEL, LLC.
K802726 11/19/1980 INSTRUMENTS NONSTERILE & STERILE ASCEP, INC.
K802570 11/14/1980 A.M.P.C.O. SKIN SCRUB TRAY ASSOCIATED MEDICAL PRODUCTS CO.
K802577 11/12/1980 HYPERALIMENTATION SUBCLAVIIAN DRESS TRAY ASSOCIATED MEDICAL PRODUCTS CO.
K802646 11/12/1980 HAND PERCUSSOR CUP #65210 B & F MEDICAL PRODUCTS, INC.
K802504 11/12/1980 SPONGE SURGICAL GUAZE RADIOPAQUE BARNHARDT MFG. CO.
K802166 11/12/1980 MODEL AS* 7B AUTOSYRINGE INFUSION PUMP BAXTER HEALTHCARE CORP.
K802594 11/12/1980 BECKMAN DP-5500 DATA REDUCTION SYSTEM BECKMAN INSTRUMENTS, INC.
K802574 11/12/1980 BECKMAN LIQUID STAT LIQUID/ALKALINE PHO BECKMAN INSTRUMENTS, INC.
K802572 11/12/1980 BECKMAN LIQUID-STAT LD-L-UV ENZYME BECKMAN INSTRUMENTS, INC.
K802581 11/12/1980 BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY BECKMAN INSTRUMENTS, INC.
K802592 11/12/1980 PARAGON SERUM PROTEIN ELECTROPHORESIS BECKMAN INSTRUMENTS, INC.
K801890 11/18/1980 IC-2 VENTILATOR BIO-MED DEVICES, INC.
K802521 11/12/1980 CK-MB(IMMUNOLOGICAL) BIODYNAMICS CORP.
K802472 11/26/1980 BIOMETRIC ERG SYSTEM BIOMETRIC ANALYSIS GROUP, INC.
K802607 11/19/1980 TERPERATUR SENSING DEVICE BURDITT & CALKINS-SIEMENS-ELEMA
K802153 11/12/1980 CBC PAP TEST KIT CALBIOCHEM-BEHRING CORP.
K801946 11/19/1980 CPR HELPER CARDIA CONCEPTS CORP.
K801947 11/19/1980 CPR TRAVELER CARDIA CONCEPTS CORP.
K801945 11/19/1980 SAVE MOR CARDIA CONCEPTS CORP.
K802058 11/19/1980 MAPPING PROBE MODEL #6540 CARDIAC PACEMAKERS, INC.
K801623 11/18/1980 CAVITRON ULTRASONIC SURG. ASPIR. CUSA CAVITRON CORP.
K802714 11/26/1980 COBE/STOCKERT BATTERY MODULE COBE LABORATORIES, INC.
K802605 11/12/1980 ELECTRO SURGICAL TIP CLEANER CONCEPT, INC.
K802221 11/19/1980 CHRONOCOR IV MODEL 250 CORDIS CORP.
K802037 11/21/1980 VITAMIN B12 FOLATE RADIOASSAY CORNING MEDICAL & SCIENTIFIC
K802782 11/19/1980 THE CRITERION II PACING SYS. MONITOR DART MEDICAL EQUIPMENT
K802602 11/12/1980 L-3 PURGE LINE DELTA MEDICAL INDUSTRIES
K802716 11/12/1980 DEN-MAT FIBER OPTIC HALOGEN LIGHT DEN-MAT CORP.
K802562 11/12/1980 PRISMA SEAL DENTSPLY INTL.
K802460 11/19/1980 HELFET ELBOW PROSTHESIS DEPUY, INC.
K801934 11/13/1980 WORRELL PATELLA FEMORAL SHIELD DEPUY, INC.
K802659 11/12/1980 RESPIRATORY THERAPY FLOWMETER DESIGN & MANUFACTURING CONSULTANTS
K802665 11/12/1980 TOUCHLESS CLEAN-CATH DIAMED DIVISION ILL. TOOL WORKS, INC.
K802664 11/12/1980 URINARY DRAINAGE UNT DIAMED DIVISION ILL. TOOL WORKS, INC.
K802710 11/12/1980 INFANT APNEA MONITOR DOUGLAS SCIENTIFIC PRODUCTS
K802707 11/12/1980 DRAGER PEEP CONTROL SYSTEM DRAEGER MEDICAL, INC.
K802764 11/24/1980 PLASTIC ADHESIVE BANDAGE DYN-A-MED PRODUCTS
K802395 11/26/1980 SPECIAL PROCEDURE AQAROSE FILM ELECTROPHORESIS CORP.
K802396 11/26/1980 GENERAL PROCEDURE AGAROSE FILM ELECTROPHORESIS CORP. OF AMERICA
K802374 11/24/1980 ROBERTSON OBTURATION MONITOR INSUFFLA ENDOTEK CORP.
K802254 11/26/1980 GENERAL ULTRASOUND EXAM. TABLE ENGINEERING DYNAMICS CORP.
K802595 11/12/1980 ERGO IRRIGATION SYSTEM ERGO INSTRUMENTS, INC.
K802819 11/24/1980 KETAC-CEM IN REF. TO K802048 ESPE DENTAL PRODUCTS
K802874 11/25/1980 ARTERIOVENOUS BLOOD TUBING SETS EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K802672 11/24/1980 CARDIOACTIVE DRUGS CONTROL FISHER SCIENTIFIC CO., LLC.
K802471 11/12/1980 CHEMTROLER FLETCHER FLORA COMPUTER PRODUCTS, INC.
K802626 11/12/1980 ANAIROBE-TEK FLOW LABORATORIES, INC.
K802591 11/12/1980 MODEL 5460 + 5480 POP-OFF VALVES G. DUNDAS CO.
K802533 11/12/1980 GAMMA LEWIS BLOOD GROUP SUBSTANCE GAMMA BIOLOGICALS, INC.
K802534 11/12/1980 GAMMA PI BLOOD GROUP SUBSTANCE GAMMA BIOLOGICALS, INC.
K802511 11/12/1980 GARELICK COMMODE GARELICK MFG. CO.
K801986 11/12/1980 DATASON DB SYSTEM GENERAL ELECTRIC CO.
K802316 11/26/1980 PDS THERMAL DILUTION CARDIAC MODULE(OUT) GENERAL ELECTRIC CO.
K802609 11/26/1980 CHEMISTRY ANALYZER IMPACT 400 GILFORD INSTRUMENT LABORATORIES, INC.
K802476 11/19/1980 CARDIACINDEX COMPUTER MODEL SP 1435 GOULD, INC.
K802232 11/12/1980 AB-TROL COAGULATION CONTROL HELENA LABORATORIES
K802191 11/12/1980 ATGM MODEL AT-80 HERALD OF AMERICA, INC.
K802686 11/26/1980 HP MODEL 8880A FILTER HEWLETT-PACKARD CO.
K802718 11/26/1980 MODEL 4700A ELECTROCARDIOGRAPH HEWLETT-PACKARD CO.
K802466 11/12/1980 DISSCAP HOLLOW FIBER DIALYZER HOSPAL MEDICAL CORP.
K802723 11/19/1980 EXTENDED BALLJOINT GRIP HOWMEDICA CORP.
K802722 11/19/1980 EXTERNAL FIXATION SYSTEM HOWMEDICA CORP.
K802776 11/19/1980 HOFFMAN LEG LENGTHENING DEVICE HOWMEDICA CORP.
K802587 11/12/1980 OTOLOGICAL VENTILATION TUBES HUMBOLDT PRODUCTS
K802866 11/17/1980 SHARPS CADDY MAGNETIC & SHARPS CADDY FOA INSTRANETICS, INC.
K802762 11/26/1980 NORMOCAP CR-102, RECORDER UNIT INSTRUMENTARIUM-DATEX
K802712 11/26/1980 ENTERMED ENTUNIT JEDMED INSTRUMENT CO.
K802713 11/19/1980 FMS-02 FLOOR-UNIT MODEL MICROSCOPE JEDMED INSTRUMENT CO.
K802603 11/12/1980 ECONO-FLOAT WHEELCHAIR FLOTATION CUSHION JEFFERSON INDUSTRIES, INC.
K802677 11/12/1980 CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON JOHNSON & JOHNSON PROFESSIONALS, INC.
K802557 11/12/1980 EMERGENCY DEPARTMENT LACERATION KIT- JOHNSON & JOHNSON PROFESSIONALS, INC.
K802193 11/12/1980 KOTEX SECURITY TUBE TAMPONS KIMBERLY-CLARK CORP.
K802812 11/26/1980 RIONET HEARING AID KINDEL & ANDERSON
K801908 11/12/1980 SI-14 KMI MEDICAL, INC.
K802373 11/12/1980 SURGICAL FACE MASK LOUIS M. GERSON CO., INC.
K802569 11/12/1980 ABNORMAL HEMOGLOBIN CONTROL MARILYN L. AMICK
K802568 11/12/1980 HEMOGLOBIN CONTROL MARILYN L. AMICK
K802763 11/26/1980 RESPIRGARD MARQUEST MEDICAL PRODUCTS, INC.
K802369 11/12/1980 12SSL ECG ANALYSIS PROG.(SCALER LEAD) MARQUETTE ELECTRONICS, INC.
K792609 11/19/1980 LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN. MEDCOR, INC.
K802564 11/12/1980 MEDICAL MAGNETIC TAPE RECORDER MEDICAL CONCEPTS, INC.
K802330 11/12/1980 HI-TEMP LOOPTIP SURGICAL CAUTERY MEDICAL PRODUCTS DEVELOPMENT, INC.
K802473 11/12/1980 BENZALKONIUM-HEPARIN COATED GUIDEWIRES MEDRAD, INC.
K802475 11/26/1980 A2 IMAGE PROCESSING SYSTEM MEDTRONIC VASCULAR
K800870 11/13/1980 MEDTRONIC MODEL 6958 MEDTRONIC VASCULAR
K802506 11/12/1980 PLEASCENT OR FORMA-SCENT MERIDIAN DIAGNOSTICS, INC.
K802524 11/12/1980 SURGICAL HAMMERS MIDSHORE WELDING CORP.
K802654 11/12/1980 AMES TDA PRIMIDONE TEST MILES LABORATORIES, INC.
K802642 11/12/1980 UTAH ARTIFICAL ARM MOTION CONTROL, INC.
K802800 11/24/1980 NARCO AIR-SHEILDS SYS. 100 MONITOR SYS NARCO AIR-SHIELDS
K802805 11/05/1980 NEMECTRODYN 5 NEMECTRON MEDICAL, INC.
K802149 11/12/1980 TM-5 INTRACRANIAL PRESSURE MONITOR NICOLET BIOMEDICAL INSTRUMENTS
K802518 11/12/1980 BUN REAGENT ASTRA 4 & 8 ANALYZERS NOBEL SCIENTIFIC INDUSTRIES, INC.
K802322 11/10/1980 MODEL SD-1 DISINTEGRATOR NORTHGATE RESEARCH, INC.
K802640 11/12/1980 OHIO GC INCUBATOR OHIO MEDICAL PRODUCTS
K802639 11/12/1980 OHIO IC INCUBATOR OHIO MEDICAL PRODUCTS
K802492 11/12/1980 REIGNING ARTIFICIAL TEETH OKI SHIKS USA LTD.
K802489 11/12/1980 REIGNING CROWN BRIDGE OKI SHIKS USA LTD.
K802490 11/19/1980 REIGNING DENTURE OKI SHIKS USA LTD.
K802491 11/12/1980 REIGNING REPAIR EPOXY RESIN OKI SHIKS USA LTD.
K802673 11/12/1980 KNEE BRACE/STABILIZER OMNI SCIENTIFIC, INC.
K802497 11/12/1980 BACTIRACIN DIAGNOSTIC DISC OXOID U.S.A., INC.
K802494 11/12/1980 GAS GENERATING KIT SYSTEM FOR CAMPYLOB. OXOID U.S.A., INC.
K802498 11/12/1980 MUELLER HINTON AGAR OXOID U.S.A., INC.
K802496 11/12/1980 OPTOCHIN DIAGNOSTIC DISC OXOID U.S.A., INC.
K802493 11/12/1980 SPUTASOL OXOID U.S.A., INC.
K802501 11/12/1980 V FACTOR DISCS OXOID U.S.A., INC.
K802502 11/12/1980 X & V FACTOR DISCS OXOID U.S.A., INC.
K802500 11/12/1980 X-FACTOR DISCS OXOID U.S.A., INC.
K802423 11/12/1980 PHADEBACT HAEMOPHILUS TEST PHARMACIA, INC.
K802652 11/12/1980 BOUNDARY SURGICAL DRAPES WITH ADHESIVE PROCTER & GAMBLE MFG. CO.
K802249 11/19/1980 MICROLET FAMILY OF NEEDLE/DEPTH ELECT- PROGRESS MANKIND TECHNOLOGY
K802152 11/19/1980 PMT DEPTHALON DEPTH " " #2102 PROGRESS MANKIND TECHNOLOGY
K802151 11/19/1980 PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC PROGRESS MANKIND TECHNOLOGY
K802243 11/12/1980 VAXIOM FAMILY OF RF LESION PROBES & ELEC PROGRESS MANKIND TECHNOLOGY
K802265 11/12/1980 CBC PLT-4 R & D SYSTEMS, INC.
K802267 11/12/1980 PLT-4 SIZE-CHECK R & D SYSTEMS, INC.
K802465 11/12/1980 BICARB-O-MATE HEMODIALYSIS SOD. BICARB. RENAL SYSTEMS, INC.
K802675 11/19/1980 ENDOTRACHEAL TUBE HOLDER RESPIRATORY SUPPORT PRODUCTS, INC.
K802694 11/12/1980 JACOB CHUCK RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K802431 11/12/1980 SCHURING OSSICLE CUP & COLUMELLA PROSTH. RICHARD'S MEDICAL EQUIP., INC.
K801922 11/12/1980 TUTTIFRUTTI (NON-PRES. SUNGLASSES) SAFETY PLASTICS OF NEW YORK
K802638 11/12/1980 OTOLOGICAL VENTILATION TUBES SANTA BARBARA MEDCO, INC.
K802333 11/12/1980 INSTANT BRIDGE SCIENTIFIC PHARMACEUTICALS, INC.
K802796 11/24/1980 CELLAMIN SECOL CO.
K802811 11/24/1980 MONOJECT ROOT CANAL FILLING MAT. NEEDLE SHERWOOD MEDICAL CO.
K801927 11/14/1980 SILENTSLEEP SLUMBER RESEARCH, INC.
K802289 11/26/1980 PERICARDIOCENTESIS KIT STANCO MEDICAL, INC.
K802287 11/20/1980 RIGHT ATRIAL LINE KIT STANCO MEDICAL, INC.
K802288 11/20/1980 SWAN GANZ CATHETER PLACEMENT KIT STANCO MEDICAL, INC.
K802560 11/12/1980 TINNITUS RESEARCH AUDIOMETER STARKEY LABORATORIES, INC.
K802509 11/12/1980 G.R.A.M. SLIDE STERILIZATION TECHNICAL SERVICES, INC.
K802278 11/24/1980 IN VITRO DIAGNOSTIC STANDARDS SUPELCO, INC.
K802703 11/12/1980 LIQUID CHROMATOGRAPHY COLUMNS SUPELCO, INC.
K802454 11/12/1980 GESTE FOLLOW KIT DETERM. OF HPL SYN-KIT, INC.
K802623 11/12/1980 EMIT-STM AMPHETAMINE ASSAY SYVA CO.
K802624 11/12/1980 EMIT-STM URINE CALIBRATORS SYVA CO.
K802637 11/26/1980 TECA MODEL-10 ELECTROMYOGRAPH TECA, INC.
K802179 11/12/1980 CARDIOSCOPE J200 TELECTRONICS, INC.
K802657 11/12/1980 MODEL AFR EEG TELEPHONE RECEIVER TELEDIAGNOSTIC SYSTEMS, INC.
K802656 11/26/1980 MODEL T-6 EEG TELEPHONE TRANSMITTER TELEDIAGNOSTIC SYSTEMS, INC.
K802597 11/12/1980 TELESONIC ARCON & SOUNDEX ASP 101 TELESONIC, INC.
K802596 11/12/1980 TELESONIC, ARCON & SOUNDEX ASP 102 TELESONIC, INC.
K802537 11/12/1980 DISPOSABLE SURGICAL DRAPE TEXAS MEDICAL PRODUCTS, INC.
K802598 11/19/1980 CARBIDE CUTTING INSTRUMENT/INTRAARTICU THE ANSPACH EFFORT, INC.
K802696 11/12/1980 DENTAL MOUTH PROP. TRIDENT DENTAL, INC.
K802611 11/12/1980 AUTO SUTURE DISPOS., EEA SURG. STAPLER U. S. SURGICAL CORP.
K802520 11/12/1980 CENTRIFICHEM PIPETTOR ACCURACY CALIB. UNION CARBIDE CORP.
K802515 11/12/1980 ROOT CANAL POST UNITEK CORP.
K802648 11/26/1980 UCA CREAM PRODUCT REFORMULATION VANARAY LABORATORIES, INC.
K802649 11/12/1980 UCA GEL PRODUCT REFORMAULATION VANARAY LABORATORIES, INC.
K802650 11/12/1980 UCA LOTION PRODUCT REFORMULATION VANARAY LABORATORIES, INC.
K802682 11/24/1980 CONTACT SEAL VIVADENT (USA), INC.
K802681 11/24/1980 HELIOBOND VIVADENT (USA), INC.
K802684 11/24/1980 HELIOMAT VIVADENT (USA), INC.
K802683 11/24/1980 HELIOSIT VIVADENT (USA), INC.
K802680 11/12/1980 ISOPAST-DS VIVADENT (USA), INC.
K802685 11/12/1980 REOLIT VIVADENT (USA), INC.
K802576 11/12/1980 EXTERNAL JUGULAR CVP CATHERIZATION KIT WILLSON
K802744 11/19/1980 FOLDING ROLL-ABOUT CHAIR WINCO WINFIELD CO., INC.
K802745 11/19/1980 FOLDING SHOWER-COMMODE CHAIR WINCO WINFIELD CO., INC.
K802803 11/19/1980 CONVALESCENT RECLINER WINFIELD CO., INC.
K802573 11/24/1980 SERUM T4 BY ENZYME IMMUNOASSAY WORTHINGTON DIAGNOSTIC SYSTEMS
K802029 11/12/1980 OBJECTIVE REFRACTOR ZEISS HUMPHREY SYSTEM
K802676 11/12/1980 ORHTOPEDIC REAMER 87 HTD ZIMMER, INC.


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