FDA 510(k) Applications Received During October, 1977

FDA 510(k) Number Submission Date Device Name Applicant Contact
K771908 10/11/1977 ISO-SHIELD SALIVA ABSORBERS 3M COMPANY
K772001 10/21/1977 SARNES HELP 3M HEALTH CARE, SARNS
K771972 10/17/1977 5UM FILTERSET WITH Y-INJECTION SITE ABBOTT LABORATORIES
K771991 10/19/1977 CARDIAC OUTPUT THERMODILUTION MODULE ABBOTT LABORATORIES
K771909 10/11/1977 DUAL WAVELENGTH PHOTOMETER, 1177 ABBOTT LABORATORIES
K772036 10/27/1977 IN-LINE BURETTE SET ABBOTT LABORATORIES
K771869 10/03/1977 DIAG. ULTRASOUND B-SCANNER ACCUSONICS, INC.
K771942 10/17/1977 TILT 10, CATALOG #S-2600 AFFILIATED HOSPITAL PRODUCTS, INC.
K771913 10/11/1977 HEEL/ELBOW PROTECTOR ALBA-WALDENSIAN, INC.
K772046 10/28/1977 INTUBATION PROCEDURE KIT AMERICAN HOSPITAL SUPPLY CORP.
K772047 10/28/1977 RESPIRATORY KIT AMERICAN HOSPITAL SUPPLY CORP.
K771914 10/12/1977 SUBJECTIVE REFRACTOR, MOSEL SR-111 AMERICAN OPTICAL CORP.
K771915 10/12/1977 MICRO OSCILLATING SAW AMERICAN STERILIZER CO.
K771980 10/17/1977 FEVER TESTER AMERICAN THERMOMETER COMPANY, INC.
K771877 10/04/1977 DIGOXIN RIA KIT ANTIBODIES INC.
K771895 10/06/1977 DINAMAP MADEL 845 APPLIED MEDICAL RESEARCH
K771896 10/06/1977 DINAMAP MODEL 835 APPLIED MEDICAL RESEARCH
K771897 10/06/1977 DINAMAP MODEL 837 APPLIED MEDICAL RESEARCH
K771981 10/18/1977 MINIMAP MODEL 810 APPLIED MEDICAL RESEARCH
K771931 10/14/1977 MONITOR, DINMAP, MODEL 850 APPLIED MEDICAL RESEARCH
K771932 10/14/1977 RECORDER, DINMAP, MODEL 950 APPLIED MEDICAL RESEARCH
K771988 10/19/1977 VERTETRAC BALLERT ORTHOPEDIC CORP.
K771983 10/18/1977 SCALP VEIN SET BERMAN, PCP & CONSULTANTS, INC.
K771894 10/06/1977 LDH ISOENZYME CONTROL BIO-REAGENTS & DIAGNOSTICS, INC.
K771867 10/03/1977 MYCOPLASMA DETECTION KIT BIOASSAY SYSTEMS RESEARCH CORP.
K771923 10/13/1977 FASTCHEM BUN BOEHRINGER MANNHEIM CORP.
K771993 10/21/1977 AFT SYSTEM CALBIOCHEM
K771933 10/14/1977 CILCO ANTERIOR CHAMBER LENS CALIFORNIA INTRAOCULAR LENS
K772027 10/27/1977 CARDIOCASSETTE II CARDIODYNE, INC.
K772015 10/25/1977 PATIENT HEATER SYSTEM, MODEL PH112 CAROLINA MEDICAL ELECTRONICS
K771865 10/03/1977 DAYSTAR SURG. LIGHT 9100 & ORBITER 9110 CASTLE CO.
K771890 10/06/1977 PERCEPTION SERIES DELIVERY SYS. CHAYES VIRGINIA, INC.
K771873 10/04/1977 VISION SERIES DENTAL CHAIR CHAYES VIRGINIA, INC.
K771878 10/04/1977 IRIDIUM 192 WIRES & PINS CIS RADIOPHARMACEUTICALS, INC.
K771985 10/19/1977 FILTER SAMPLER BLOOD SERUM FILTER CLASROCK
K772017 10/26/1977 IN VITRO THEOPHYLLINE RIA TEST CLINICAL ASSAYS, INC.
K771929 10/14/1977 PEDIATRICS GOWN CONVERTORS
K772011 10/25/1977 WHOLEY OCCLUSION BALLOON CATHETER COOK, INC.
K771992 10/21/1977 L-501 CARDIAC PACEMAKER CORATOMIC, INC.
K772053 10/31/1977 LINE CHARGER MODEL LC-100 DATASCOPE CORP.
K772056 10/31/1977 PHYSIOLOGICAL MONITOR MODEL 871 DATASCOPE CORP.
K772052 10/31/1977 PHYSIOLOGICAL RECORDER MODEL 721A DATASCOPE CORP.
K772054 10/31/1977 PHYSIOLOGICAL RECORDER MODEL 740 DATASCOPE CORP.
K771971 10/17/1977 HYDROMASSAGE EQUIP. MODEL 1000 DAZEY PRODUCTS CO.
K771969 10/17/1977 TURBO-JET MODEL 76 DAZEY PRODUCTS CO.
K771966 10/17/1977 VIBRO BATH MODEL FS-1 DAZEY PRODUCTS CO.
K771967 10/17/1977 WHIRLPOOL BATH MODEL 2270 DAZEY PRODUCTS CO.
K771968 10/17/1977 WHIRLPOOL BATH MODEL 2273 DAZEY PRODUCTS CO.
K771970 10/17/1977 WHIRLPOOL BATH MODEL 50 DAZEY PRODUCTS CO.
K771973 10/17/1977 GINGITRACT DEN-MAT CORP.
K771974 10/17/1977 SOLVENEX I-0 DEN-MAT CORP.
K771965 10/17/1977 WHIRLPOOL BATH MODEL 2274 DOZEY PRODUCTS CO.
K771989 10/19/1977 CONTINUOUS FLOW ANESTHESIA MACHINE DRAEGER MEDICAL, INC.
K771899 10/06/1977 VAPOR 19 DRAEGER MEDICAL, INC.
K771924 10/13/1977 HEARTBEATER DUNN INSTRUMENTS, INC.
K771898 10/06/1977 AUTOMATED SLIDE SPINNER DYNATECH CRYOMEDICAL CO.
K771866 10/03/1977 TROUTMAN CORNEAL PUNCH EDWARD WECK, INC.
K771987 10/19/1977 MICROPULSE 26U PULSE GENERATOR EDWARDS PACEMAKER SYSTEMS
K772059 10/31/1977 CATHETER, PACING/MONITORING ELECTRO-CATHETER CORP.
K771994 10/21/1977 ELECTROTHERM MODEL HT-1 ELECTROMEDICS, INC.
K771999 10/21/1977 ELECTROTHERM MODELS F&C18,14,78, F84 ELECTROMEDICS, INC.
K771995 10/21/1977 ELECTROTHERM MODELS TC-100 & M-99 ELECTROMEDICS, INC.
K771996 10/21/1977 TELETHERMOMETER MODEL T T-100 ELECTROMEDICS, INC.
K771997 10/21/1977 TELETHERMOMETER MODEL T T-400 ELECTROMEDICS, INC.
K771998 10/21/1977 TEMP-A-LERT MODEL TA-986 ELECTROMEDICS, INC.
K771978 10/17/1977 CTR 100L EMI MEDICAL, INC.
K771930 10/14/1977 EMISONIC 4500 TM EMI MEDICAL, INC.
K771902 10/06/1977 EMI FOUR EMI THERAPY SYSTEMS, INC.
K771885 10/05/1977 IMPORTED PAIN CONTROL DEVICE EMPI
K771901 10/07/1977 CAPMIX ESPE DENTAL PRODUCTS
K771889 10/06/1977 UNIOLITE ESPE DENTAL PRODUCTS
K771956 10/17/1977 HUMAN O BUFFER FLOW LABORATORIES, INC.
K771957 10/17/1977 RUBELLA HEMAGGLUTINATION REAGENT KIT FLOW LABORATORIES, INC.
K771955 10/17/1977 TRYPSIN 1% FLOW LABORATORIES, INC.
K771976 10/17/1977 ECG AMPLIFIER/R WAVE TRIGGER G.D. SEARLE AND CO.
K772004 10/21/1977 HUMAN C4 COMPLEMENT CONTROL SERUM G.D. SEARLE AND CO.
K772003 10/21/1977 HUMAN REFERENCE SERUM C4 COMPLEMENT G.D. SEARLE AND CO.
K771934 10/14/1977 LINEAR ARRAY B-MODE SCANNER G.D. SEARLE AND CO.
K772002 10/21/1977 PLATES FOR HUMAN C4 COMPLEMENT G.D. SEARLE AND CO.
K772024 10/26/1977 RX LENS SERIES GENTEX CORPORATION
K771870 10/04/1977 MARTIN LEWIS AGAR (JEMBEC) GRANITE DIAGNOSTICS, INC.
K771871 10/04/1977 MARTIN LEWIS AGAR (PLATE) GRANITE DIAGNOSTICS, INC.
K771872 10/04/1977 MARTIN LEWIS TRANSGROW GRANITE DIAGNOSTICS, INC.
K772049 10/31/1977 WALKING AID GUARDIAN PRODUCTS CO., INC.
K771928 10/14/1977 CALCIUM SET, ITEM NO. 65004 HARLECO
K772029 10/27/1977 GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT HARLECO
K772032 10/27/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP HARLECO
K772033 10/27/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* HARLECO
K772034 10/27/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1 HARLECO
K772030 10/27/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT HARLECO
K772028 10/27/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH HARLECO
K772035 10/27/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL HARLECO
K772031 10/27/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT HARLECO
K771927 10/14/1977 IRON SET, ITEM NO. 65008 HARLECO
K771925 10/14/1977 KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP HARLECO
K771926 10/14/1977 TOTAL PROTEIN SET, ITEM NO. 64010 HARLECO
K772048 10/24/1977 SINGLE & DUAL CHANNEL RECORDER HEWLETT-PACKARD CO.
K772012 10/25/1977 VIDEO ADAPTER FOR GRAPHIC RECORDERS HONEYWELL, INC.
K771883 10/04/1977 REPLICA ACID-ETCH HOYT LABORATORIES
K771881 10/04/1977 REPLICA BONDING AGENT HOYT LABORATORIES
K771880 10/04/1977 REPLICA DENTAL COMPOSIT HOYT LABORATORIES
K771882 10/04/1977 REPLICA DENTAL COMPOSITE-RADIOPAQUE HOYT LABORATORIES
K771879 10/04/1977 GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K771912 10/11/1977 LAS-R BETA LIPOPROTEIN TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K771922 10/13/1977 MINICLINIC TM INSTROMEDIX, INC.
K771977 10/17/1977 CARDIAC OUTPUT COMPUTER MODEL 701 INSTRUMENTATION LABORATORY CO.
K771953 10/17/1977 GASTRIN RIA MODULE INTER SCIENCE INSTITUTE
K771948 10/17/1977 GLUCAGON RIA MODULE INTER SCIENCE INSTITUTE
K771947 10/17/1977 INSULIN RIA MODULE INTER SCIENCE INSTITUTE
K772057 10/31/1977 BIPOLAR PACEMAKER MODEL 224 INTERMEDICS, INC.
K771874 10/03/1977 J-VAC VACUUM TUBE JELCO LABORATORIES
K772020 10/26/1977 CLOTH ADHESIVE TAPE JOHNSON & JOHNSON PROFESSIONALS, INC.
K771958 10/17/1977 12MM SELF-SEALING TROCAR & CANNULA KLI
K771959 10/17/1977 8MM SELF-SEALING TROCAR & CANNULA KLI
K771964 10/17/1977 8MM TROCAR & CANNUAL W/STOPCOCK KLI
K771962 10/17/1977 CAMERA ADAPTER FOR ENDOSCOPES KLI
K771961 10/17/1977 DUAL INCISION TUBAL OCCLUS. BAND APPLI. KLI
K771963 10/17/1977 SINGLE INCISION TUBAL OCCLU. BAND APPL. KLI
K771960 10/17/1977 TUBAL OCCLUSION INSERTER/LAPAROSCOPE KLI
K771935 10/14/1977 DIGITAL THERMOMETER MEDICAL NETWORKS
K771862 10/03/1977 TRANSFUSION BLOOD FILTER MEDICAL, INC.
K771911 10/11/1977 PLASTIC STOPCOCK W/ EXTENSION TUBE MEDON CORP.
K772058 10/31/1977 LEAD ADAPTOR KIT MODEL 5866-21 MEDTRONIC VASCULAR
K772013 10/25/1977 PERCUPASS TUNNELING TOOL MODEL 3452 MEDTRONIC VASCULAR
K772000 10/21/1977 ECG TELEMETRY SYSTEM MENNEN GREATBATCH ELECTONICS
K772005 10/21/1977 MYOTONE EMG MONITOR MICROTRONICS CORP.
K772014 10/25/1977 AMES T-4 STRIP TEST MILES LABORATORIES, INC.
K772039 10/28/1977 BETA-HCG RIA MONITOR SCIENCE CORP.
K772038 10/28/1977 KANAMYCIN RIA MONITOR SCIENCE CORP.
K771921 10/12/1977 HYDRON ROOT CANAL FILLING SYSTEM NATIONAL PATENT DEVELOPMENT CORP.
K772060 10/31/1977 PROTECT IV GARD OMNICON MEDICAL CORP.
K771990 10/19/1977 OMNIMEDICAL 400L OMNIMEDICAL SERVICES, INC.
K771941 10/17/1977 QUANTROLS IM ORGANON, INC.
K771940 10/17/1977 QUANTROLS RF ORGANON, INC.
K771888 10/05/1977 SYRINGE, DISPOSABLE ORTHOPEDIC EQUIPMENT CO., INC.
K772051 10/31/1977 MDL-201 PACESETTER SYSTEMS
K772050 10/31/1977 TDL-100 B PACESETTER SYSTEMS
K772023 10/21/1977 OB/GYN LASER, MODEL 920 PHOTON SOURCES
K772006 10/21/1977 ACUTE CARDIAC CARE SYSTEM PHYSIO-CONTROL CORP.
K772055 10/31/1977 PENTAX F.O.-IT OBSERVER SCOPE PILLING CO.
K771892 10/06/1977 VALVE ANESTHETIC PROMED CORP.
K771918 10/12/1977 FIBEO OPTICS ILLUM. SYSTEM PROPPER MFG. CO., INC.
K771920 10/12/1977 FIBER OPTICS PROCTOSCOPE PROPPER MFG. CO., INC.
K771919 10/12/1977 FIBER OPTICS SIGMOIDOSCOPE PROPPER MFG. CO., INC.
K771975 10/17/1977 ARTERIAL BLOOD SAMPLING TRAY RESPIRATORY CARE, INC.
K772016 10/25/1977 RESPITRACE RESPITRACE CORP.
K771936 10/17/1977 MICROBIOLOGICAL CULTURE MEDIUM SCOTT LABORATORIES, INC.
K771876 10/04/1977 ARGYLE PEOCUSSOR SYSTEM SHERWOOD MEDICAL INDUSTRIES
K771916 10/11/1977 PROCEDURE NO. 555 SIGMA CHEMICAL CO.
K771904 10/07/1977 GLYCEROL KINASE SIMMLER & SON, INC.
K771905 10/07/1977 GLYCEROL SUBSTRATE SIMMLER & SON, INC.
K771903 10/07/1977 LIPASE SIMMLER & SON, INC.
K771906 10/07/1977 PHOSPHATE SIMMLER & SON, INC.
K772043 10/28/1977 ALPHA/CHOL STANDARD SCIENTIFIC, INC.
K772008 10/20/1977 SCALP VEIN SETS SURU CHEMICALS & PHARMACEUTICALS, LTD.
K771939 10/17/1977 STAC SYSTEM-ADDI. ANALYTES TECHNICON INSTRUMENTS CORP.
K772044 10/28/1977 TECHSIGHT LENSES WITH ZUMA COATING TECHSIGHT CORP.
K772026 10/27/1977 CARDIAC PULSE GENERATOR, MODEL 150L TELECTRONICS, INC.
K772040 10/28/1977 TRANSDUCER PROTECTOR TERUMO AMERICA, INC.
K771986 10/19/1977 CATHETER, MEDIASTINAL&PERICARDIAL THE MINNESOTA BACK BRACE CO.
K771938 10/17/1977 ALGINATE IMPRESSION MATERIAL THE S. S. WHITE CO.
K771861 10/03/1977 CATHETER, CEBTRAL VENOUS, 2N1501 TRAVENOL LABORATORIES, S.A.
K771891 10/06/1977 CATHETER, UMBILICAL, VICRA TRAVENOL LABORATORIES, S.A.
K771875 10/05/1977 ULTRAFILTRATION MONITOR 5M9034 TRAVENOL LABORATORIES, S.A.
K771979 10/17/1977 CENTRIA INSULIN RIA UNION CARBIDE CORP.
K771982 10/18/1977 888 ARTERIAL/VENOUS CATHETER INTRODUCER USCI, DIV. C.R. BARD, INC.
K772021 10/26/1977 TRC STAINLESS STEEL SAFETY SPRING GUIDES USCI, DIV. C.R. BARD, INC.
K772022 10/26/1977 SPECTROPHOTOMETER CARY 219 VARIAN ASSOC., INC.
K772010 10/25/1977 CARDIAC PACEMAKER C2001 VITATRON MEDICAL BV
K772009 10/25/1977 CARDIAC PACEMAKER S6001 VITATRON MEDICAL BV
K771900 10/06/1977 71110 DESK CHARGER WELCH ALLYN, INC.
K771864 10/03/1977 WALL TRANSFORMERS 74710 & 74910 WELCH ALLYN, INC.
K771886 10/05/1977 ACCU-PAQUE WILLIAMS GOLD REFINING CO., INC.
K771887 10/05/1977 ACCU-STAIN WILLIAMS GOLD REFINING CO., INC.
K771863 10/02/1977 COLOR COTE WILLIAMS GOLD REFINING CO., INC.
K772025 10/27/1977 URIC ACID STD. FOR QUANT. URIC ACID WORTHINGTON BIOCHEMICAL CORP.


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