FDA 510(k) Decisions During April, 1978  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K780616 04/19/1978 HYDRON BURN DISPOSABLE DISPENSER SET ABBOTT LABORATORIES
K780606 04/19/1978 BANDAGE ABCO DEALERS, INC.
K780603 04/21/1978 COLD PACK ABCO DEALERS, INC.
K780600 04/19/1978 IRRIGATION TRAY ABCO DEALERS, INC.
K780595 04/19/1978 MINI-IRRIGATION TRAY ABCO DEALERS, INC.
K780604 04/19/1978 SHAVE PREP ABCO DEALERS, INC.
K780612 04/19/1978 STOCKINETTE, STERILE ABCO DEALERS, INC.
K780596 04/19/1978 STOPCOCK ABCO DEALERS, INC.
K780602 04/19/1978 SYRINGE (IRRIGATION) ABCO DEALERS, INC.
K780599 04/19/1978 SYRINGE, EAR & ULCER ABCO DEALERS, INC.
K780591 04/19/1978 THERMOMETER KIT ABCO DEALERS, INC.
K771614 04/12/1978 AUTO. WELL TYPE GAMMA COUNTERS ACTUS, INC.
K771612 04/10/1978 WELL TYPE GAMMA COUNTER ACTUS, INC.
K771613 04/10/1978 WELL TYPE GAMMA COUNTER ACTUS, INC.
K780472 04/19/1978 INFANT INCUBATOR AIR-SHIELDS, INC.
K780503 04/10/1978 INFUSION PUMP AIR-SHIELDS, INC.
K780547 04/10/1978 STERILE ORTHOPEDIC STOCKINETTE ALBA-WALDENSIAN, INC.
K780570 04/19/1978 TUBULAR DRESSING RETAINER ALBA-WALDENSIAN, INC.
K780492 04/28/1978 GAMMA STIK 125I T3 UPTAKE KIT ALPHA GAMMA LABORATORY
K780488 04/12/1978 INSTRUMENT AND ACCESSORY KIT AMERICAN HOSPITAL SUPPLY CORP.
K780336 04/03/1978 URINE SAMPLE KIT AMERICAN HOSPITAL SUPPLY CORP.
K780443 04/24/1978 SGOT/AST REAGENT SYSTEM AMERICAN MONITOR CORP.
K780343 04/18/1978 ARRHYTHMIA TREND ENHANCEMENT AMERICAN OPTICAL CORP.
K780625 04/28/1978 UNISTAT OXIMETER AMERICAN OPTICAL CORP.
K780516 04/28/1978 GENTAMICIN RIA KIT ANTIBODIES INC.
K780358 04/28/1978 ACCES. ANALOG OUTPUT ADAPTOR MODEL 910 APPLIED MEDICAL RESEARCH
K780259 04/18/1978 CATHETERIZATION TRAY & KIT ARGON MEDICAL CORP.
K780532 04/21/1978 PERCUTANEOUS SHEATH INTRODUCER KIT ARROW INTL., INC.
K780312 04/05/1978 AUTONOM AUTONOMIC EQUIPMENT SUPPLY CO,
K780617 04/18/1978 EQUALIZER BALLERT ORTHOPEDIC CORP.
K780530 04/28/1978 AUTOMATED PHYSIOLOGIC PROFILER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780097 04/24/1978 QUALITY CONTROL SYSTEM, SPECTRA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780556 04/24/1978 SPECT RIM (LISS) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780477 04/13/1978 PHYSIOLOGICAL PRESSURE TRANSDUCER BELL & HOWELL INSTRUMENTS
K780357 04/05/1978 TITANIUM MULLER TOTAL HIP BIOMET, INC.
K780510 04/18/1978 NUCLEAR STETHOSCOPE BIOS, INC.
K780439 04/18/1978 PRECIMAT GLYCEROL BOEHRINGER MANNHEIM CORP.
K780563 04/18/1978 SINGLE VIAL LACTATE BOEHRINGER MANNHEIM CORP.
K780475 04/24/1978 DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT BURROUGHS WELLCOME CO.
K780409 04/27/1978 COLOPLAST-DURASEAL OSTOMY APPLIANCE C.R. BARD, INC.
K780347 04/12/1978 RIA SYS. FOR HUMAN GROWTH HORMONE CALBIOCHEM-BEHRING CORP.
K780367 04/28/1978 RIA SYS. FOR HUMAN LUTEINIZING HORMONE CALBIOCHEM-BEHRING CORP.
K780666 04/27/1978 DAYSTAR SELECTRA & SELECTRA/ORBITER CASTLE CO.
K780337 04/12/1978 THERMOLYSIS GENERATOR CLARE, INC.
K780366 04/07/1978 SOLID-OX EMERGENCY OXYGEN CLEANWELD PRODUCTS, INC.
K780498 04/05/1978 CBR-DIGOXIN ANTISERUM CLINICAL BIORESEARCH
K780387 04/12/1978 VABRA ABORTION UNIT COOPER LABORATORIES
K780401 04/24/1978 THYRO-ZYME-T4 ASSAY KIT COULTER ELECTRONICS, INC.
K780496 04/18/1978 TRAVELAIR AND STATIONAIR CRYOMED CORP.
K780546 04/10/1978 BEHIND-THE-EAR MASKING AMPLIFIER,735S DANAVOX, INC.
K780485 04/05/1978 PREBYPASS FILTER DELTA MEDICAL INDUSTRIES
K780518 04/28/1978 ULTRANOVAR, DENTAL U.V. CURING LAMP DEMETRON RESEARCH CORP.
K780469 04/10/1978 PANORAMIC X-RAY, DENTAL DEN-TAL-EZ MFG CO., INC.
K780494 04/10/1978 AMIKACIN DIAGNOSTIC PRODUCTS CORP.
K780495 04/10/1978 DIGITOXIN DIAGNOSTIC PRODUCTS CORP.
K780470 04/27/1978 H.P. MEDICAL GRADE SILICONE TUBING DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K780454 04/21/1978 ACTIVE-LIFE E. R. SQUIBB & SONS, INC.
K780511 04/21/1978 SNAP-FIT E. R. SQUIBB & SONS, INC.
K780295 04/05/1978 CALIBRATORS, CARBON DIOXIDE E.I. DUPONT DE NEMOURS & CO., INC.
K772387 04/05/1978 LEAD HAND EDWARD WECK, INC.
K780493 04/10/1978 ELECATH PLASTIC JACKETED GUIDEWIRE ELECTRO-CATHETER CORP.
K780359 04/04/1978 OXYGEN REGULATOR/FLOWMETER ERIE MFG., CO.
K780567 04/28/1978 AORTIC PUMP ETHICON, INC.
K780244 04/13/1978 CATHETERS, ARTERIAL EMBOLECTOMY EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K780566 04/21/1978 HEALTH SEAT SYSTEM G & W APPLIED SCIENCE LABORATORIES
K780480 04/18/1978 CT/T INDEPENDENT DIAGNOSTIC CENTER GENERAL ELECTRIC CO.
K780491 04/18/1978 DATA CAMERA GENERAL ELECTRIC CO.
K780533 04/18/1978 PRE-REDUCED MEDIA GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K780425 04/28/1978 BIOPHYSICAL MONITORING SYSTEM GOULD, INC.
K780137 04/28/1978 CLAMP, INCONTINENCE, BAUMRUCKER GREENWALD SURGICAL CO., INC.
K780429 04/18/1978 TOURNEQUET, NON-PNEUMATIC HEMOX, INC.
K780417 04/18/1978 ASEPTIC TRANSFER SET HEYER SCHULTE CORP.
K780414 04/10/1978 OCTOPUS HITRON CORP.
K780640 04/28/1978 DRY SILVER PROCESSOR MODEL 1226 HONEYWELL, INC.
K780535 04/27/1978 HUMIDIFIER FILTER HUDSON OXYGEN THERAPY SALES CO.
K780262 04/05/1978 DIRECT UREA NITROGEN TEST HYCEL, INC.
K780526 04/28/1978 CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM I M, INC.
K780437 04/05/1978 PACEMAKER, MODEL 252, C-MOS INTERMEDICS, INC.
K780175 04/21/1978 RATE PROGRAMMER MODEL 520 INTERMEDICS, INC.
K780321 04/04/1978 PREGNANCY TEST KIT, OVER-THE-COUNTER INTL. DIAGNOSTIC, INC.
K780416 04/21/1978 PANTRIDGE MK III DEFIBRILLATOR/MONITOR IPCO CORP.
K780386 04/13/1978 K-Y LUBRICATING JELLY JOHNSON & JOHNSON PROFESSIONALS, INC.
K780251 04/06/1978 NEPHELOMETER KALLESTAD LABORATORIES, INC.
K780560 04/21/1978 DENTAL AMALGAMATOR L.D. CAULK CO.
K780575 04/18/1978 LASCHAL SCISSOR LASCHAL INSTRUMENT CORP.
K780538 04/19/1978 AUDIO MONITOR-MODEL 8309 LIFE-TECH INSTRUMENTS, INC.
K780540 04/21/1978 ELECTRIC RESPONSE AUDIOMETER LIFE-TECH INSTRUMENTS, INC.
K780344 04/12/1978 GAMMA COUNTER LKB INSTRUMENTS, INC.
K780351 04/24/1978 NORMAL UNASSAYED CONTROL SERA MACOMB CHEMICAL CO.
K780353 04/05/1978 DRI-LYTE MALLINCKRODT CRITICAL CARE
K780440 04/10/1978 CHAMBER, AEROBIC MARION LABORATORIES, INC.
K780489 04/12/1978 SPINE BOARD MARULLO, BALDWIN, FRIEDEN, GATEWOOD,
K780370 04/10/1978 STAND UP TOILET MEDICAL SPECIALTY PRODUCTS, INC.
K780371 04/10/1978 TILT TYPE AC POWERED HOSPITAL BED MEDICAL SPECIALTY PRODUCTS, INC.
K780646 04/28/1978 AIR-PWOERED COLDRILL MEDISHIELD, INC.
K780444 04/19/1978 NERVTRON-RX MEDIX CORP.
K780302 04/21/1978 BLOOD FLOWMETER SYSTEM MEDTRONIC VASCULAR
K780114 04/19/1978 IMMUNOZYME E. HISTOLYTICA ANTIGENS MILLIPORE CORP.
K780551 04/19/1978 I.V. ADMINISTRATION SET WITH MINI-SPIKE NATIONAL PATENT DEVELOPMENT CORP.
K780549 04/19/1978 NON-STICK PADS NATIONAL PATENT DEVELOPMENT CORP.
K780550 04/19/1978 STERILE AIR SYRINGE NATIONAL PATENT DEVELOPMENT CORP.
K780405 04/05/1978 INFANT ELECTROSURGICAL GROUNDING PAD NEW DIMENSIONS IN MEDICINE, INC.
K780490 04/10/1978 NEIA-FERRITIN ENZYMEIMMUNOASSAY NEW ENGLAND IMMUNOLOGY ASSOC.
K780279 04/10/1978 ICE-PAK, PDI NICE-PAK PRODUCTS, INC.
K772116 04/28/1978 AMINOGLYCOSIDE TEST SYSTEM NICHOLS INSTITUTE DIAGNOSTICS
K780415 04/10/1978 VIVONEX DELIVERY SYSTEM NORWICH PHARMACAL CO.
K780502 04/10/1978 NOVA AIR FLOATATION SYSTEM NOVA HEALTH SYSTEMS, INC.
K780644 04/28/1978 RADIOASSAY FOR TOTAL SERUM THYROXINE NUCLEAR DIAGNOSTICS, INC.
K780486 04/28/1978 STIKSEP-T3 KIT NUCLEAR DIAGNOSTICS, INC.
K780308 04/12/1978 OREIA-T4 ORGANON, INC.
K780654 04/28/1978 HEARING AID, EARETTE OTICON CORP.
K780413 04/24/1978 LOW IIONIC STRENGTH SOLUTION PFIZER, INC.
K780331 04/06/1978 CHOLESTEROL RAPID SLAT KIT HDL PIERCE CHEMICAL CO.
K780168 04/18/1978 PARAMEDIC O2 KIT POHLMANN RESCUE PRODUCTS, INC.
K780528 04/19/1978 PREMIER CARVERS, STYLE #21C & 21D PREMIER DENTAL PRODUCTS CO.
K780422 04/04/1978 PINWHEEL PROJECTS IN HEALTH
K780426 04/27/1978 BODY WARMER Q-MATIC CORP.
K780643 04/27/1978 SHADOW-CATHS QUINTON, INC.
K780562 04/27/1978 AQUAPAK PREFILLED HUMIDIFIER RESPIRATORY CARE, INC.
K780580 04/27/1978 TEMPERATURE INDICATOR RESPIRATORY CARE, INC.
K780299 04/27/1978 TOTAL KNEE SYSTEM RICHARD'S MEDICAL EQUIP., INC.
K780678 04/28/1978 IMPRESSION TRAY ROCKY MOUNTAIN ORTHODONTICS, INC.
K780255 04/18/1978 NEEDLE DRIVER SCANLAN INTL., INC.
K780311 04/05/1978 DIAGNOSTIC KIT, CPK SCLAVO, INC.
K780188 04/10/1978 INFANT VENTILATOR MODEL 100 SECHRIST INDUSTRIES, INC.
K780261 04/18/1978 COVERSLIPPER SHANDON, INC.
K780220 04/10/1978 HOOD, INFANT OXYGEN SHILEY, INC.
K780355 04/18/1978 ATROXIN SIGMA CHEMICAL CO.
K780209 04/10/1978 DILUTION SPIKE STERLING DRUG, INC.
K780483 04/28/1978 FIBER OPTIC HANDPIECE SYNTEX CORP.
K780380 04/12/1978 ANALYZER, FAST, CENTRIFUGAL, GEMSAEC SYVA CO.
K780461 04/12/1978 ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 SYVA CO.
K780467 04/24/1978 EMIT ANTIEPILEPTIC DRUG CALIBRATORS SYVA CO.
K780466 04/24/1978 EMIT CARBAMAZEPINE ASSAY SYVA CO.
K780441 04/12/1978 THEOPHYLLINE ASSAY TO THE CENTRIFICHEM SYVA CO.
K780442 04/12/1978 THEOPHYLLINE ASSAY TO THE GEMSAEC SYVA CO.
K780411 04/13/1978 TAYLOR CATHETER HOLDER TAYLOR CATHETER HOLDER MFG.
K780448 04/19/1978 TRANSPORTABLE OXYGEN PURITY ANALYZER TAYLOR INSTRUMENT ANALYTICS CO.
K780544 04/24/1978 DISC-PAK ROTATOR TECHHNILAB INSTRUMENTS, INC.
K780373 04/28/1978 STAC SYSTEM TECHNICON INSTRUMENTS CORP.
K780641 04/21/1978 DENTAL ROTARY CARBIDE BURS 76EJL TELEDYNE DENSCO
K780418 04/10/1978 BURN DRESSING PAD THE OWENBY CO.
K780129 04/05/1978 ATOMIZER, FURNACE, GRAPHITE THE PERKIN-ELMER CORP.
K780342 04/10/1978 SPECTROPHOTOMETERS THE PERKIN-ELMER CORP.
K780394 04/10/1978 GAUZE FLUFF THE TORRENT CORP.
K780318 04/12/1978 MODULAR SCANNING DENSITOMETER SYS. TRANSIDYNE GENERAL CORP.
K780407 04/10/1978 2C7125 BLOW BOTTLE TRAVENOL LABORATORIES, S.A.
K780406 04/12/1978 2C7153 NEBULIZER CAP TRAVENOL LABORATORIES, S.A.
K780517 04/13/1978 CARDIOTOMY RESERVOIR TRAVENOL LABORATORIES, S.A.
K780481 04/10/1978 I.V. LEVER CLAMP TRAVENOL LABORATORIES, S.A.
K780456 04/12/1978 NEBULIZER HEATER TRAVENOL LABORATORIES, S.A.
K780119 04/03/1978 NEBULIZER, DISP, 2D0815 TRAVENOL LABORATORIES, S.A.
K780223 04/10/1978 PARENTERAL INFUSION CONTROLLER TRAVENOL LABORATORIES, S.A.
K780531 04/13/1978 MILLER TABLE VICTOR JOHN MANLEY
K780215 04/10/1978 EYESCOPE VISUAL METHODS, INC.
K770534 04/21/1978 THERAPEUTIC APPARATUS, DIERKER TYPE WELL BEING ENT.
K780131 04/10/1978 THERMOMETER, DIGITAL, NTM-100 WILTON WEBSTER LABORATORIES
K780389 04/19/1978 HDL REAGENT SET FOR LIPOPROTEINS WORTHINGTON BIOCHEMICAL CORP.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact