FDA 510(k) Applications Received During June, 1978

FDA 510(k) Number Submission Date Device Name Applicant Contact
K781021 06/19/1978 AIR BUBBLE DETECTOR 3M HEALTH CARE, SARNS
K780942 06/07/1978 BLOOD PUMP MODEL 7000 3M HEALTH CARE, SARNS
K781000 06/15/1978 PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS ABBOTT LABORATORIES
K780979 06/09/1978 AIRSTIRRUP PNEUMATIC ANKLE BRACE AIRCAST, INC.
K780927 06/05/1978 TI-COMFORTER ALDEN PRODUCTS CO.
K780957 06/12/1978 SET, ADMINISTRATION, MANUAL, DIALYSIS AMERICAN MEDICAL PRODUCTS, INC.
K780971 06/12/1978 CLINICAL ACQUISITION MODULE ANALYTICAL DEVELOPMENT ASSOC. CORP.
K780908 06/05/1978 SELF-RETAINING ELECTRODE SER. #4000-100 ANDOVER MEDICAL, INC.
K781053 06/22/1978 DINAMAP MODEL 846 APPLIED MEDICAL RESEARCH
K781064 06/26/1978 DINAMAP MODEL 848 APPLIED MEDICAL RESEARCH
K780915 06/05/1978 780 SE (BEHIND THE EAR) ARGOSY INTL. (USA), INC.
K780916 06/05/1978 780 UE (BEHIND THE EAR) ARGOSY INTL. (USA), INC.
K781095 06/30/1978 HEARING AID, BEHIND THE EAR ARGOSY INTL. (USA), INC.
K781094 06/30/1978 HEARING AID, EYEGLASS ARGOSY INTL. (USA), INC.
K781096 06/30/1978 HEARING AID, EYEGLASS, B-12 ARGOSY INTL. (USA), INC.
K780919 06/05/1978 M25 PP (BEHIND THE EAR) ARGOSY INTL. (USA), INC.
K780920 06/05/1978 MM-CE 11 (BEHIND THE EAR) ARGOSY INTL. (USA), INC.
K780921 06/05/1978 MM-CE DM (BEHIND THE EAR) ARGOSY INTL. (USA), INC.
K780914 06/05/1978 PM 25 PP (BODY AID) ARGOSY INTL. (USA), INC.
K780917 06/05/1978 PRIMO CE (BEHIND THE EAR) ARGOSY INTL. (USA), INC.
K780918 06/05/1978 PRIMO CEDM (BEHIND THE EAR) ARGOSY INTL. (USA), INC.
K780922 06/05/1978 UM VII (BEHIND THE EAR) ARGOSY INTL. (USA), INC.
K780978 06/09/1978 SINGLE USE ACTIVE ELECTRODE HANDLE ASPEN LABORATORIES, INC.
K780976 06/09/1978 SINGLE USE BALL ELECTRODE ASPEN LABORATORIES, INC.
K780977 06/09/1978 SINGLE USE BLADE ELECTRODE ASPEN LABORATORIES, INC.
K780975 06/09/1978 SINGLE USE NEEDLE ELECTRODE ASPEN LABORATORIES, INC.
K781080 06/28/1978 GALVANATOR, MODEL 770 AVRA CORP.
K781072 06/26/1978 TRAP-BLOOD VESSEL STABILIZATION DEVICE AYER, PATRICK, M.D.
K781007 06/19/1978 AUTO-CON BARNES-HIND, INC.
K781036 06/19/1978 AUTO-SYRINGE INFUSION SET BAXTER HEALTHCARE CORP.
K780939 06/08/1978 BARD-PARKER ARTERIAL MONITORING SYSTEM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780913 06/05/1978 ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM BECKMAN INSTRUMENTS, INC.
K781041 06/20/1978 ELECTROENCEPHALOGRAPH ACCUTRACE 100 BECKMAN INSTRUMENTS, INC.
K781005 06/19/1978 ELECTROENCEPHALOGRAPH ACCUTRATE 200 BECKMAN INSTRUMENTS, INC.
K781093 06/30/1978 HDL CENTRIFIKIT BECKMAN INSTRUMENTS, INC.
K781006 06/19/1978 IMMUNOCHEMISTRY SYS. MANUAL MODE BECKMAN INSTRUMENTS, INC.
K780897 06/01/1978 GENERATOR, PULSE, SORIN MODEL DL-1 BENTLEY LABORATORIES, INC.
K780980 06/12/1978 PLATELET CONTROL BHP DIAGNOSTIX, INC.
K781075 06/28/1978 STATTEK-GLUCOSE LOW LEVEL BOEHRINGER MANNHEIM CORP.
K780993 06/14/1978 ULTRASOUND IMAGING SYSTEM BOEHRINGER MANNHEIM CORP.
K781014 06/16/1978 AUTOREFRACTOR, SUBJECTIVE CAVITRON CORP.
K780964 06/12/1978 TRANSPORT INCUBATOR CAVITRON CORP.
K781040 06/20/1978 CT SCANNER ND 8000 CGR MEDICAL CORP.
K781039 06/19/1978 OXY-ON DIGITAL OXYGEN TIMER CHAMBERS & SADLER MFG.
K780982 06/14/1978 KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT CIS RADIOPHARMACEUTICALS, INC.
K780934 06/08/1978 IN VITRO TOBRAMYCIN RIA KIT CLINICAL ASSAYS, INC.
K781058 06/23/1978 C-DAK 4000 ARTIFICIAL KIDNEY CORDIS CORP.
K781013 06/16/1978 ENZYMATIC REAGENT FOR CHOLESTEROL MEAS COULTER ELECTRONICS, INC.
K781083 06/29/1978 DENTAL SILICONE IMPRESSION MATERIAL CROWN DELTA CORP.
K781059 06/26/1978 CUTTER/COMPUR MINI CENTRIFUGE CUTTER LABORATORIES, INC.
K781077 06/28/1978 CONTROL, HEMATOLOGY, CH-60 DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K781012 06/16/1978 RIA TEST KIT SYS. DAMON KIQUISOL FREE DAMON CORP.
K781088 06/29/1978 OSTOMY APPLIANCE BELT E. R. SQUIBB & SONS, INC.
K780944 06/08/1978 LIQUID CHROMATOGRAPH MODEL 850 E.I. DUPONT DE NEMOURS & CO., INC.
K780945 06/08/1978 LIQUID CHROMATOGRAPH MODEL 860 E.I. DUPONT DE NEMOURS & CO., INC.
K780933 06/07/1978 PREP I AUTOMATED SAMPLE PROCESSOR E.I. DUPONT DE NEMOURS & CO., INC.
K781042 06/20/1978 PROLITH 23S PACEMAKER EDWARDS PACEMAKER SYSTEMS
K780930 06/06/1978 5543 INDEPENDENT VIEWING SYSTEM EMI MEDICAL, INC.
K780995 06/14/1978 COMPUTERIZED AXIAL TOMOGRAPHY EMI MEDICAL, INC.
K780928 06/05/1978 CT5137 HIGH RESOLUTION OPTION EMI MEDICAL, INC.
K781051 06/22/1978 EMISONIC 4201 EMI MEDICAL, INC.
K780948 06/09/1978 SYSTEM, PLANNING, TREATMENT EMI THERAPY SYSTEMS, INC.
K781084 06/29/1978 THERAPAX 150A EMI THERAPY SYSTEMS, INC.
K781009 06/19/1978 ANALYZER, SERUM IRON & TOTAL IRON BINDIN ENVIRONMENTAL SCIENCES ASSOC., INC.
K781002 06/15/1978 TEMPORARY CARDIAC PACING WIRE ETHICON, INC.
K780994 06/14/1978 CERVICAL COLLAR FOX INSTRUMENTS, INC.
K780906 06/02/1978 AIR-FLO ALTERNATING PRESSURE PAD SYSTEM GAYMAR INDUSTRIES, INC.
K780963 06/12/1978 X-RAY SYSTEM GENERAL X-RAY, INC.
K781030 06/19/1978 X-RAY UNIT, PORTABLE GX-101 AEC GENERAL X-RAY, INC.
K780907 06/02/1978 MIC-2000 GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K780999 06/09/1978 X-RAY FRAME HOLDER GREAT EASTERN LUMBER CO., INC.
K780936 06/08/1978 PHONIC EAR HC ELECTRONICS
K781050 06/21/1978 DLC 500, DOUBLE LUMEN CATHETER HEMODIALYSIS, DIVISION OF THE
K781037 06/19/1978 PRESSURE INFUSION DEVICE HINCK MEDICAL, INC.
K780938 06/08/1978 SUPER-SORBER HOME HEALTHCARE PRODUCTS, INC.
K781055 06/23/1978 FACE TENTS HOSPITAK, INC.
K781045 06/21/1978 A-33 DENTAL ALLOY HOWMEDICA CORP.
K781004 06/16/1978 HMA URIC ACID TEST HYCEL, INC.
K780946 06/09/1978 ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER HYCEL, INC.
K780905 06/02/1978 LIMB COVER HYDRO-MED PRODUCTS, INC.
K780962 06/12/1978 AUTOMATED ENZYME HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K781023 06/19/1978 ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU ICL SCIENTIFIC
K781017 06/16/1978 ANTI-HUMAN C1 INHIBITOR SERUM (GOAT) ICL SCIENTIFIC
K781022 06/19/1978 ANTI-HUMAN CIQ SERUM ICL SCIENTIFIC
K781015 06/16/1978 ANTI-HUMAN LDL SERUM ICL SCIENTIFIC
K781026 06/19/1978 ANTITHROMBIN III SERUM, ANTI-HUMAN ICL SCIENTIFIC
K781016 06/16/1978 C3PA (GBG) PROPERDIN FACTOR B ICL SCIENTIFIC
K781024 06/19/1978 CERUOPLASMIN SERUM ANTI-HUMAN ICL SCIENTIFIC
K781028 06/19/1978 KAPPA SERUM (FREE & BOUND) ANTI-HUMAN ICL SCIENTIFIC
K781027 06/19/1978 KAPPA SERUM (FREE) ANTI-HUMAN ICL SCIENTIFIC
K781025 06/19/1978 LAMBDA SERUM (FREE) ANTI-HUMAN ICL SCIENTIFIC
K781054 06/21/1978 LIFELINE AMBULATORY IMC
K781048 06/21/1978 THC DIRECT RIA KIT IMMUNALYSIS CORPORATION
K781081 06/27/1978 EMIT MCA PROGRAM TAPE INSTRUMENTATION LABORATORY CO.
K780998 06/14/1978 SCALPEL ISOLAB, INC.
K781076 06/28/1978 CHEMISTRY ANALYZER JOHNS SCIENTIFIC, INC.
K780924 06/05/1978 ELECTROSURGICAL GROUNDING PAD CABLE JOHNSON & JOHNSON PROFESSIONALS, INC.
K781011 06/12/1978 K-Z CONCENTRATE K-ZYME LABS, INC.
K780899 06/02/1978 FLUORESCENT ANTI-NATIVE DNA TEST KALLESTAD LABORATORIES, INC.
K781109 06/30/1978 FORCEPS, ELECTROSURGICAL KLI
K781089 06/29/1978 ONE INCISION BI-POLAR ELECTRO. FORCEPS KLI
K780954 06/09/1978 SCISSORS, HOOK, ELECTROSURGICAL KLI
K780955 06/09/1978 SCISSORS, HOOK, ELECTROSURGICAL KLI
K781242 06/12/1978 ALLOY, AMALGAM, DISP. CAPSULE LEE PHARMACEUTICALS
K780967 06/12/1978 LEE-ALLOY LEE PHARMACEUTICALS
K780966 06/12/1978 LEE-ALLOY DISPOSABLE CAPSULES LEE PHARMACEUTICALS
K781243 06/12/1978 MERCURY DISP. CAPSULE LEE PHARMACEUTICALS
K780965 06/12/1978 NEW RESTODENT LEE PHARMACEUTICALS
K781018 06/16/1978 DX TOOTHBRUSH LEVER BROTHERS COMPANY, INC.
K780925 06/06/1978 EB-VCA, TEST, ANTIBODY, FLUORESCENT LITTON BIONETICS
K781044 06/22/1978 ULTRASONIC DENTAL PROPHYLAXIS UNIT,SSM LITTON DENTAL PRODUCTS
K780969 06/12/1978 GAMMA CAMERA MACHLETT LABORATORIES, INC.
K781128 06/30/1978 LDH (UV KINETIC) MACOMB CHEMICAL CO.
K781107 06/30/1978 DISPENSER, GAS XENON MALLINCKRODT CRITICAL CARE
K781008 06/19/1978 ISOTONIC DILUENT MALLINCKRODT CRITICAL CARE
K781062 06/26/1978 DROPPER, SOLUTION TRICHROME, CEPTI-SEAL MARION LABORATORIES, INC.
K781061 06/26/1978 DROPPERS, SOLUTION, IODINE MARION LABORATORIES, INC.
K780941 06/07/1978 CONDUCTIVE CUSHION MARKHAM SERVICE CO., INC.
K781087 06/29/1978 MEDICAL GRADE SILICONE ELASTOMER TUBING MCGHAN MEDICAL CORP.
K780956 06/09/1978 OTOLOGICAL VENTILATION TUBES MCGHAN MEDICAL CORP.
K780987 06/14/1978 SOFT SILICONE ELASTOMER SPONGE EXPLANT MEDICAL INSTRUMENT RESEARCH ASSOC., INC.
K780952 06/09/1978 MODEL 1812 CONTROL CONSOLE, ACCESSORIEX MEDTRONIC VASCULAR
K780953 06/09/1978 MODEL 1861 BLOOD PUMP MEDTRONIC VASCULAR
K780996 06/13/1978 RUBELISA TEST KIT MICROBIOLOGICAL ASSOC.
K781086 06/29/1978 INSULIN AUTOPAK MICROMEDIC SYSTEMS
K781108 06/30/1978 MICROCULT-GC CULTURE TEST MILES LABORATORIES, INC.
K781043 06/20/1978 CEA-IMMERSIBLE SEPARATOR MILLIPORE CORP.
K780949 06/09/1978 BIO-MONITOR AMIKACIN MONITOR SCIENCE CORP.
K780951 06/09/1978 BIO-MONITOR GENTAMICIN MONITOR SCIENCE CORP.
K780950 06/09/1978 BIO-MONITOR TOBRAMYCIN MONITOR SCIENCE CORP.
K781032 06/19/1978 AQUA-GEL MURRAY, SALK, INC.
K780988 06/14/1978 DEVIN-NESTOR PNEUMATIC TOURNIQUET NESTOR ENGINEERING ASSOCIATES, INC.
K780989 06/14/1978 DEVIN-NESTOR SQUARE KNIFE NESTOR ENGINEERING ASSOCIATES, INC.
K780992 06/14/1978 MILLARD MOUTH GAG NESTOR ENGINEERING ASSOCIATES, INC.
K780991 06/14/1978 PARALLEL BLADE MARKER NESTOR ENGINEERING ASSOCIATES, INC.
K780990 06/14/1978 STAINLESS STEEL TEMPLATE NESTOR ENGINEERING ASSOCIATES, INC.
K780985 06/14/1978 PVC LINES FOR MONITORING NORTON PERFORMANCE PLASTICS CORP.
K780984 06/14/1978 PVC QUICK PRIME LINES NORTON PERFORMANCE PLASTICS CORP.
K781079 06/28/1978 SONOGRAF ULTRASOUND B-SCANNING SYSTEM OHIO NUCLEAR, INC.
K780901 06/01/1978 AUTOMATED ELECTROPHORESIS SYSTEM OLYMPUS CORP.
K780972 06/12/1978 QUICKRATE REACTION RATE ANALYZER OLYMPUS CORP.
K781082 06/29/1978 CAST BLOCK ORTHOPEDIC EQUIPMENT CO., INC.
K781001 06/15/1978 CHAIRS WITH CASTORS ORTHOPEDIC EQUIPMENT CO., INC.
K780935 06/07/1978 GRAB BAR ORTHOPEDIC EQUIPMENT CO., INC.
K780912 06/05/1978 ADJUSTABLE DISPENSOR OXFORD LABORATORIES, INC.
K781031 06/19/1978 AEROPLAST DRESSING PARKE-DAVIS CO.
K780973 06/12/1978 SIGNAPAD PARKER LABORATORIES, INC.
K781070 06/26/1978 SECOND ANTIBODY PCL-RIA, INC.
K781071 06/26/1978 STANDARDS, HORMONE, THYROID STIMULATING PCL-RIA, INC.
K781069 06/26/1978 T3 STANDARDS IN HUMAN SERUM PCL-RIA, INC.
K780981 06/14/1978 PORTABLE PNEUMATIC CALIBRATOR 65-150 PENNWALT CORP.
K781085 06/29/1978 ASSURE NATURAL FIT TAMPON PERSONAL PRODUCTS CO.
K781033 06/19/1978 HEARING AID PHONEMICS, INC.
K780958 06/12/1978 MUELLER HINTON AGAR WITH 5% SHEEP BLOOD PITTSBURGH MICRO-MEDIA, INC.
K780959 06/12/1978 MUELLER HINTON AGAR WITH THYMIDINE PITTSBURGH MICRO-MEDIA, INC.
K781052 06/22/1978 CONTINUOUS EPIDURAL ANESTHESIA TRAY PORTEX, INC.
K781035 06/19/1978 PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX PREMIER DENTAL PRODUCTS CO.
K781034 06/19/1978 PREMIER INLAY PLACER PREMIER DENTAL PRODUCTS CO.
K781056 06/23/1978 DIGITAL IMAGE MEMORY/PROCESSOR QUANTEX CORP.
K781038 06/19/1978 HYDRAULIC SUCTION BIOPSY PUMP MODEL 7MM QUINTON, INC.
K781779 06/05/1978 SANI-DENT DENTURE CLEANER SANDI-DENT
K780943 06/07/1978 BUN TEST UNI-UV BLOOD UREA NITROGEN TEST SCLAVO, INC.
K780986 06/14/1978 DIGITAL BLOOD PRESSURE MONITOR SEARS, ROEBUCK & CO.
K780937 06/08/1978 MODEL 20 DIGITAL PULSE RATE MONITOR SENTRONIX, INC.
K781060 06/26/1978 MONOJECT ENDOSSEOUS DENTAL IMPLANT SHERWOOD MEDICAL INDUSTRIES
K780983 06/14/1978 CALCIUM REAGENT SYSTEM NO. 585 SIGMA CHEMICAL CO.
K780931 06/06/1978 SOFT LENS INSERTER SOFT-SERT
K781047 06/21/1978 DRAPE, SURGICAL-SPARTAN LIMB SHEET SPARTAN HEALTHCARE PRODUCTS CO.
K781046 06/21/1978 IMPERVIOUS STOCKINET SPARTAN HEALTHCARE PRODUCTS CO.
K780997 06/14/1978 AMALGAM ALLOY SYNTEX CORP.
K781068 06/26/1978 AUTOMATIC FILM PROCESSORIO M. R80 TECNOMED, INC.
K781065 06/26/1978 PLURIMAT;RADIOGRAPHIC TUBE MOUNT TECNOMED, INC.
K781067 06/26/1978 PLURIX B; RADIOGRAPHIC TABLE TECNOMED, INC.
K781066 06/26/1978 PLURIX C; RADIOGRAPHIC TABLE TECNOMED, INC.
K780940 06/08/1978 GENERATOR, PULSE, MODEL 160B TELECTRONICS, INC.
K781073 06/26/1978 PULMO-SONIC THE DEVILBISS CO.
K781020 06/15/1978 (AST) OR (ALT) UV DETERM. PHY. PHOS. THE DOW CHEMICAL CO.
K781010 06/16/1978 MERCURY/HYDRIDE ATOMIC ABSORPTION ACCESS THE PERKIN-ELMER CORP.
K780909 06/01/1978 SYSMEX AUTO. BLOOD CELL COUNTER, CC-120 TOA MEDICAL ELECTRONICS USA, INC.
K780911 06/01/1978 SYSMEX PLATELET COUNTER, PL-110 TOA MEDICAL ELECTRONICS USA, INC.
K780910 06/01/1978 SYSTEM AUTO. BLOOD CELL COUNTER CC-110 TOA MEDICAL ELECTRONICS USA, INC.
K780970 06/12/1978 BURETTE SET WITH AIR CONTROL LEVER TRAVENOL LABORATORIES, S.A.
K780898 06/02/1978 INSTANT CURE-1 ULTRA-LIGHT CORP.
K780947 06/09/1978 510 BEDSIDE X-RAY SYSTEM UNION CARBIDE CORP.
K780974 06/09/1978 BACILLUS PUMILUS UROL, INC.
K781057 06/23/1978 CLINAC 20 (OPTIONAL 18 MV VERSION) VARIAN ASSOC., INC.
K780960 06/12/1978 SERUM, CONTROL, DRUGS, ANTIARRYTHMIC VITEK SYSTEMS, INC.
K780961 06/12/1978 THEOPHYLLINE CONTROL SERUM VITEK SYSTEMS, INC.
K781029 06/19/1978 OTOSCOPE, DIAG. MODELS 20100 & 20200 WELCH ALLYN, INC.
K780932 06/06/1978 MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT WESTERN LABORATORIES CORP.
K781049 06/22/1978 ACU-TEST IN-HOME PREGNANCY TEST WILLIAMS, THE J.B. CO., INC.
K781074 06/29/1978 OXYGEN RICH AIR SUPPLY UNIT-MODEL 390 XORBOX
K780929 06/05/1978 COTTON TIPPED POINT YOUNG DENTAL MANUFACTURING CO 1, LLC.


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