FDA 510(k) Decisions During December, 1977  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K771320 12/06/1977 CRYOSURGICAL EQUIPMENT A.S.M.O.T.
K771909 12/20/1977 DUAL WAVELENGTH PHOTOMETER, 1177 ABBOTT LABORATORIES
K772094 12/08/1977 LIFECARE I.V. PUMP - MODEL III ABBOTT LABORATORIES
K772193 12/02/1977 NASSAL PRESSURE/FLOW RECORDER ADCO LABS.
K772200 12/08/1977 YASARGIL ANEURYSM CLIPS AESCULAP INSTRUMENTS CORP.
K772227 12/20/1977 CATH KIT, SUPERPUBIC AMERICAN HOSPITAL SUPPLY CORP.
K772215 12/22/1977 UNCONJUGATED ESTRIOL RIA KIT AMERSHAM CORP.
K772135 12/08/1977 BIOLOGICAL/CHEMICAL INDICATOR AMSCO CO.
K772169 12/02/1977 AUDIOMETER, RECORDING, AUTOMATIC B&K INSTRUMENTS, INC.
K772098 12/20/1977 DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771737 12/20/1977 SUCTION CANISTER BEMIS HEALTH CARE
K771894 12/22/1977 LDH ISOENZYME CONTROL BIO-REAGENTS & DIAGNOSTICS, INC.
K772235 12/13/1977 HAND CONTROL ACCESS.-ELECTROSURG. UNITS CAMERON-MILLER, INC.
K771043 12/20/1977 SWAN GANZ CLINCAL INSTRUMENTS CORP.
K772109 12/06/1977 IN VITRO HUMAN TSH RIA TEST CLINICAL ASSAYS, INC.
K772218 12/13/1977 CATHETER, SILICONE COATED CONCORD LABORATORIES, INC.
K771609 12/20/1977 PEDIATRIC THYROXINE TEST SYS. T4 CORNING MEDICAL & SCIENTIFIC
K772183 12/20/1977 THYROID BINDING GLOBULIN CORNING MEDICAL & SCIENTIFIC
K772225 12/08/1977 PATELLAR PROSTHESIS CUTTER LABORATORIES, INC.
K772292 12/20/1977 T-TUBE WHELAN-MOSS DAVOL, INC.
K772120 12/20/1977 TOTAL HIP, CHARNELY TYPE DEPUY, INC.
K772129 12/08/1977 MEDI-JECTOR DERATA CORP.
K772188 12/22/1977 FSH RIA KIT (125I) DIAGNOSTIC PRODUCTS CORP.
K772307 12/22/1977 PCO 2 ELECTROLYTE FISHER SCIENTIFIC CO., LLC.
K772106 12/06/1977 PH CALIBRATION BUFFERS GENERAL DIAGNOSTICS
K772283 12/15/1977 RX PEDESTAL TABLE GENERAL ELECTRIC CO.
K772184 12/22/1977 X-RAY SYSTEM FOR DENTAL APPLICATION GENERAL ELECTRIC CO.
K772232 12/15/1977 LIQUID NITROGEN SPRAY UNIT GILMORE LIQUID AIR CO.
K772243 12/22/1977 TOXO TEST GULL LABORATORIES, INC.
K772157 12/06/1977 CREATININE, 64972 HARLECO
K772156 12/06/1977 ULTRACHEM PHOSPHORUS, 64973 HARLECO
K772155 12/06/1977 ULTRACHEM TOTAL PROTEIN, #64974 HARLECO
K772286 12/20/1977 FORCEPS, SUTURE, AUTO HARTMANN GROUP, INC.
K772140 12/05/1977 SCANNING SYS., AUTO. COMP., ACS1000 HONEYWELL, INC.
K772217 12/13/1977 TEMPERATURE MONITOR HUDSON OXYGEN THERAPY SALES CO.
K771445 12/14/1977 HERPES I.D. TM TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K772233 12/20/1977 THERMOMETER RECAL ADAPTER INFO-CHEM
K772199 12/13/1977 CAUTERIES, HOT WIRE, DISP. INTERMEDICS, INC.
K772172 12/06/1977 DYNAZYME TM II CARDIAK-MB J.T. BAKER CHEMICAL CO.
K771874 12/02/1977 J-VAC VACUUM TUBE JELCO LABORATORIES
K772248 12/22/1977 ALBUMIN NEPHELOMETRIC ASSAY KALLESTAD LABORATORIES, INC.
K772250 12/22/1977 ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY KALLESTAD LABORATORIES, INC.
K772246 12/22/1977 ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY KALLESTAD LABORATORIES, INC.
K772249 12/22/1977 COMPLEMENT C3 NEPHELOMETRIC ASSAY KALLESTAD LABORATORIES, INC.
K772247 12/22/1977 COMPLEMENT C4 NEPHELOMETRIC ASSAY KALLESTAD LABORATORIES, INC.
K772245 12/22/1977 HAPTOGLOBIN NEPHELOMETRIC ASSAY KALLESTAD LABORATORIES, INC.
K772251 12/22/1977 IMMUNOGLOBULIN A NEPHEL. ASSAY KALLESTAD LABORATORIES, INC.
K772252 12/22/1977 IMMUNOGLOBULIN G NEPHEL. ASSAY KALLESTAD LABORATORIES, INC.
K772254 12/22/1977 IMMUNOGLOBULIN M NEPHEL. ASSAY KALLESTAD LABORATORIES, INC.
K772253 12/22/1977 TRANSFERRIN NEPHELOMETRIC ASSAY KALLESTAD LABORATORIES, INC.
K772242 12/20/1977 LAPAROSCOPY CONSOLE MODEL VIII KLI
K772220 12/13/1977 PROBE, COAGULATION ACCESSORY KLI
K772176 12/20/1977 CYSTIC FIBROSIS TESTING INSTRUMENT LABORATORY EQUIPMENT DESIGN CO.
K771662 12/06/1977 AUTOMATIC ANALYZER LACHAT CHEMICALS, INC.
K772211 12/22/1977 TEMP. ACRYLIC LACTONG CORP.
K772201 12/20/1977 HEARING AID, BODY TYPE, MODEL H MAICO HEARING INSTRUMENTS, INC.
K771701 12/13/1977 VESSEL-CLUDE MED GENERAL
K771702 12/13/1977 VESSEL-STABILIZER MED GENERAL
K772268 12/20/1977 DEMI-WALKER (REGULAR) MEDFUSION SYSTEMS, INC.
K772267 12/20/1977 QUADRAPLEGIC WALKING AID MEDFUSION SYSTEMS, INC.
K772269 12/20/1977 SETUP WALKER ADJUSTABLE MEDFUSION SYSTEMS, INC.
K772270 12/20/1977 SETUP WALKER OVER TOILET CONSTRUC. MEDFUSION SYSTEMS, INC.
K772271 12/20/1977 WALKER FOLDING ADJUSTABLE MEDFUSION SYSTEMS, INC.
K771935 12/08/1977 DIGITAL THERMOMETER MEDICAL NETWORKS
K772138 12/20/1977 ENDOTRACHEAL TUBE MEDLINE INDUSTRIES, INC.
K771911 12/08/1977 PLASTIC STOPCOCK W/ EXTENSION TUBE MEDON CORP.
K772202 12/20/1977 PULSE GENERATOR, A-V SEQ. MEDTRONIC VASCULAR
K772088 12/06/1977 AMES T-3 UPTAKE STRIP TEST MILES LABORATORIES, INC.
K771672 12/09/1977 MICROCULT-ID MILES LABORATORIES, INC.
K771854 12/22/1977 SPINSEP-T3 NUCLEAR DIAGNOSTICS, INC.
K772177 12/22/1977 TRI-TAB-RIA NUCLEAR MEDICAL LABORATORIES, INC.
K772181 12/20/1977 PROPHYLACTIC OM INDUSTRIES, INC.
K772060 12/20/1977 PROTECT IV GARD OMNICON MEDICAL CORP.
K772289 12/21/1977 SCANNER, CT, 0400 PFIZER MEDICAL SYSTEMS, INC.
K772291 12/21/1977 DIAG. CONSOLE, INDEPENDENT PFIZER, INC.
K772136 12/20/1977 PERITONEAL CYCLER & MANIFOLD SET PHYSIO-CONTROL CORP.
K772209 12/20/1977 CULTURE COLLEC. TRANS. SYS., DOUBLE DRY PRECISION DYNAMICS CORP.
K772205 12/09/1977 CULTURE COLLEC. TRANS. SYS., DOUBLE WET PRECISION DYNAMICS CORP.
K772210 12/09/1977 CULTURE COLLEC. TRANS. SYS., DOUBLE WET PRECISION DYNAMICS CORP.
K772208 12/09/1977 CULTURE COLLEC. TRANS. SYS., SINGLE DRY PRECISION DYNAMICS CORP.
K772206 12/09/1977 CULTURE COLLEC. TRANS. SYS., SINGLE WET PRECISION DYNAMICS CORP.
K772207 12/20/1977 CULTURE COLLEC. TRANS. SYS., SINGLE WET PRECISION DYNAMICS CORP.
K772301 12/20/1977 LAPAROSCOPY DRAPE, BOUNDARY PROCTER & GAMBLE MFG. CO.
K771429 12/22/1977 DISP. TEFLON CONNHCTOR QUINTON, INC.
K771426 12/20/1977 PEDIATRIC INFUSION "T" QUINTON, INC.
K771574 12/06/1977 LEE ASPIRATION NEEDLE RADIATION DEVELOPMENT CO., INC.
K772066 12/20/1977 PULLEN PLASTIC-PORE PLUGS RICHARD'S MEDICAL EQUIP., INC.
K771936 12/06/1977 MICROBIOLOGICAL CULTURE MEDIUM SCOTT LABORATORIES, INC.
K772237 12/13/1977 OXYGENATOR, BUBBLE SHILEY, INC.
K771904 12/06/1977 GLYCEROL KINASE SIMMLER & SON, INC.
K771905 12/06/1977 GLYCEROL SUBSTRATE SIMMLER & SON, INC.
K771903 12/06/1977 LIPASE SIMMLER & SON, INC.
K771906 12/06/1977 PHOSPHATE SIMMLER & SON, INC.
K772196 12/22/1977 RECEPTAL ATS TRAUMA KGA1900L SORENSEN RESEARCH
K772257 12/22/1977 ALKALINE PHOSPHATASE TEST SET STANBIO LABORATORY
K771300 12/08/1977 INTRAVENOUS INFUSION PUMP STEWART-NAUMANN LABORATORIES
K772224 12/15/1977 NERVE STIMULATOR, ELEC. TRANSCUTANEOUS STIMULATION TECHNOLOGY, INC.
K772182 12/08/1977 SURGICAL GOWN, REINFORCED SURGIKOS, INC.
K772178 12/08/1977 PACER MONITOR, PULSE WIDTH SURVIVAL TECHNOLOGY, INC.
K772164 12/02/1977 PANORAMIC X-RAY SYSTEM MODEL A SYBRON CORP.
K772179 12/20/1977 EMIT ANTIEPILEPTIC DRUG ASSAYS SYVA CO.
K772170 12/22/1977 EMIT CENTRIFICHEM THYROXINE ASSAY SYVA CO.
K772222 12/22/1977 NEBULIZER SET-2C7105 TRAVENOL LABORATORIES, S.A.
K771589 12/13/1977 AUTO SUTURE U. S. SURGICAL CORP.
K772299 12/21/1977 TRANSPARENT MANIFOLD UNI-RESEARCH
K771823 12/20/1977 CATHETER, CARDIOVASCULAR USCI, DIV. C.R. BARD, INC.
K772198 12/05/1977 CT SCANNER DIAGNOSTIC CONSOLE, REMOTE VARIAN ASSOC., INC.
K772213 12/13/1977 LAMP DELIVERY SYS.-PHOTOCOAGULATION VARIAN ASSOC., INC.
K772214 12/13/1977 OPHTHALMOSCOPE, BINOCULAR, INDIRECT VARIAN ASSOC., INC.
K772306 12/22/1977 125I DIGOXIN TEST SET WIEN LABORATORIES, INC.


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