FDA 510(k) Applications Received During July, 1978

FDA 510(k) Number Submission Date Device Name Applicant Contact
K781098 07/03/1978 BRUSH, APPLICATOR 3M COMPANY
K781097 07/03/1978 INOCULUM STDIZING SYS., INOCUPAC 3M COMPANY
K781145 07/10/1978 MONITOR KITS, BLOOD LEVEL 3M HEALTH CARE, SARNS
K781228 07/17/1978 PENLIGHTS ABCO DEALERS, INC.
K781279 07/26/1978 SUCTION CANISTER ABCO DEALERS, INC.
K781227 07/18/1978 TOWELS, SHEETS, PILLOWCASES ABCO DEALERS, INC.
K781251 07/21/1978 THREADED PIN, SELF DRILLING ACE ORTHOPEDIC MANUFACTURING CO.
K781276 07/24/1978 X-RAY, PORTABLE AIR-SHIELDS, INC.
K781241 07/19/1978 UNISTAT BILIRUBINOMETER AMERICAN OPTICAL CORP.
K781324 07/31/1978 ALP TEST ANALYTICAL & RESEARCH CHEMICALS, INC.
K781308 07/28/1978 GLUCOLOUR ANALYTICAL & RESEARCH CHEMICALS, INC.
K781307 07/28/1978 GLUCOSE DETERM. KIT ANALYTICAL & RESEARCH CHEMICALS, INC.
K781309 07/28/1978 GOT PROCEDURE ANALYTICAL & RESEARCH CHEMICALS, INC.
K781323 07/31/1978 LDH PROCEDURE ANALYTICAL & RESEARCH CHEMICALS, INC.
K781305 07/28/1978 UREA NITROGEN ANALYTICAL & RESEARCH CHEMICALS, INC.
K781306 07/28/1978 UREA NITROGEN TEST KIT ANALYTICAL & RESEARCH CHEMICALS, INC.
K781283 07/26/1978 READER, INOCULUM, STDIZED. ANALYTICAL PRODUCTS, INC.
K781311 07/31/1978 ELECTRODE, NEEDLE, CFM APPLIED MEDICAL RESEARCH
K781278 07/25/1978 GLOVES, PROCEDURE ARBROOK MFG. CORP.
K781135 07/07/1978 INGROWN TOENAIL APPLIANCE, OR BARMORE, BARBARA
K781138 07/06/1978 SPECTROPHOTOMETER BAUSCH & LOMB, INC.
K781303 07/27/1978 BIO-PRO UNIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781149 07/11/1978 CPK-L TUBE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781100 07/03/1978 DELTA TEST AMYLASE/LIPASE CONTS. I,II BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781153 07/10/1978 KIDNEY, ARTIFICIAL BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781182 07/14/1978 MICRO THYROXINE REAGENT SYSTEM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781304 07/27/1978 TRANSPORT MEDIA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781300 07/28/1978 OXYGEN CONCENTRATOR BENDIX INSTRUMENTS & LIFE SUPPORT DIV
K781247 07/21/1978 QUANTICEL-HRP BHP DIAGNOSTIX, INC.
K781170 07/14/1978 QUANTIMUNE HTSH IRMA HUMAN THYROID BIO-RAD
K781091 07/03/1978 KNEE INSTRUMENTATION, CONDYLAR BIOMET, INC.
K781294 07/27/1978 PROSTHESIS, KNEE, TOTAL BIOMET, INC.
K781152 07/10/1978 ELECTROCARDIOGRAPHIC ECG RECORDER CARDIO-DYNAMICS LABORATORIES, INC.
K781136 07/07/1978 TEMPERATURE MODULE, DUAL CAVITRON CORP.
K781207 07/14/1978 DOUCHE KIT, SOMETHING PERSONAL CHATTEN DRUG & CHEMICAL CO.
K781313 07/31/1978 VISION-STIMULATOR, CAM CLEMENT CLARKE, INC.
K781235 07/19/1978 IV VITRO GAMMADAB T4 RIA KIT CLINICAL ASSAYS, INC.
K781268 07/24/1978 CHAIR, VESTIBULAR, ROTARY, COMPUT. CONTRAVES
K781099 07/03/1978 SURGICAL GOWNS AND DRAPES CONVERTORS
K781238 07/20/1978 KIDNEY, ARTIFICIAL, C-DAK 1.5 CORDIS CORP.
K781237 07/20/1978 KIDNEY, ARTIFICIAL, C-DAK 2.0 CORDIS CORP.
K781217 07/17/1978 DATA TERMINAL MODEL 722 CORNING MEDICAL & SCIENTIFIC
K781253 07/21/1978 BUN (UREASE) REAGENT COULTER ELECTRONICS, INC.
K781321 07/31/1978 TENS-O-TEST CUROMATIC, INC.
K781166 07/12/1978 MONITOR, HEART RATE CYBERNETIC MEDICAL, INC.
K781212 07/17/1978 HEARING AID, MODEL 783DU DANAVOX, INC.
K781165 07/12/1978 CHOLESTEROL & HDL CHOL. PROCEDURE DATA MEDICAL ASSOCIATES, INC.
K781163 07/12/1978 ELECTRODE, DEIP. DATASCOPE CORP.
K781210 07/17/1978 HEAT EXCHANGER, FHX-14 DELTA MEDICAL INDUSTRIES
K781244 07/19/1978 TEMP. CROWN MSTERIAL FOR TEETH DEN-MAT CORP.
K781151 07/10/1978 REPROSIL DENTSPLY INTL.
K781169 07/13/1978 IMAGE DERINGER-NEY INC.
K781150 07/10/1978 RIA TSH IN HUMAN SERUM OR PLASMA DIAGNOSTIC CORP. OF AMERICA
K781310 07/31/1978 HUMAN CHORIONIC GONADO.-BETA RIA KIT DIAGNOSTICS BIOCHEM CANADA, INC.
K781214 07/17/1978 CAMERAS, MULTI-IMAGE DUNN INSTRUMENTS, INC.
K781245 07/17/1978 LUNG EXER. BAG, POST-OP, MODIFIED DYTEK CORP.
K781144 07/10/1978 ANALYZER, PACER SYSTEM, PSA-5 EDWARDS PACEMAKER SYSTEMS
K781111 07/03/1978 LEAD CONVERSION KIT, MODEL 341 EDWARDS PACEMAKER SYSTEMS
K781124 07/03/1978 CPK ISOENZYME REAGENT ELECTROPHORESIS CORP. OF AMERICA
K781118 07/03/1978 ECA BUFFER PH 8.8 ELECTROPHORESIS CORP. OF AMERICA
K781116 07/03/1978 ECA BUFFER, PH 816 ELECTROPHORESIS CORP. OF AMERICA
K781119 07/03/1978 ECA HEME BUFFER ELECTROPHORESIS CORP. OF AMERICA
K781117 07/03/1978 ECA PREP ELECTROPHORESIS CORP. OF AMERICA
K781121 07/03/1978 HEMOLYSE ELECTROPHORESIS CORP. OF AMERICA
K781125 07/03/1978 LDH ISOENZYME REAGENT ELECTROPHORESIS CORP. OF AMERICA
K781122 07/03/1978 LIPOPROTEIN STAIN ELECTROPHORESIS CORP. OF AMERICA
K781123 07/03/1978 PONCEAU S ELECTROPHORESIS CORP. OF AMERICA
K781120 07/03/1978 TRICHLORACETIC ACID 7.5% ELECTROPHORESIS CORP. OF AMERICA
K781178 07/10/1978 PULSE GENERATOR MODEL 208 ELEMA-SCHONANDER, INC.
K781176 07/12/1978 PATIENT AID, MODEL DM-351 EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K781215 07/17/1978 TEST MODULE MODEL DM-352 EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K781246 07/21/1978 FOAM COMFORT RINGS FIBRE FORMATIONS, INC.
K781233 07/19/1978 IV ARMBOARDS FIBRE FORMATIONS, INC.
K781195 07/14/1978 BAG, WALDER FRED SAMMONS, INC.
K781194 07/14/1978 BAG, WHEELCHAIR FRED SAMMONS, INC.
K781198 07/14/1978 BOARD, SCOOTER FRED SAMMONS, INC.
K781201 07/14/1978 BOARD, TRANSFER, FENDER FRED SAMMONS, INC.
K781204 07/14/1978 BOOK HOLDER FRED SAMMONS, INC.
K781206 07/14/1978 FOOT POSITIONER FRED SAMMONS, INC.
K781199 07/14/1978 HOLDER, CARD, QUAD-QUIP FRED SAMMONS, INC.
K781193 07/14/1978 KNIFE, LARGE HANDLE FRED SAMMONS, INC.
K781192 07/14/1978 KNIFE, ROCKER, SLOTTED HANDLE FRED SAMMONS, INC.
K781200 07/14/1978 NAIL CLIPPERS, ONE-HANDED FRED SAMMONS, INC.
K781191 07/14/1978 SPORKS, PLASTIC, DISP. FRED SAMMONS, INC.
K781197 07/14/1978 STICK, UTILITY FRED SAMMONS, INC.
K781205 07/14/1978 TOILET AID FRED SAMMONS, INC.
K781203 07/14/1978 TRAY, LAP, MOLDED FRED SAMMONS, INC.
K781196 07/14/1978 UTENSILS, WEIGHTED FRED SAMMONS, INC.
K781202 07/14/1978 VEST, SUPPORT, TRUNK FRED SAMMONS, INC.
K781102 07/03/1978 DIALYZER, DISP., COIL, LUNDIA GAMBRO, INC.
K781318 07/31/1978 DYNATRON 406 ELECTROTHERAPY APPARATUS GENERAL THERAPHYSICAL, INC.
K781315 07/31/1978 MUSCLE STIMULATION APPARATUS GENERAL THERAPHYSICAL, INC.
K781316 07/31/1978 PULSED AND CONTINUOUS SHORTWAVE APPAR. GENERAL THERAPHYSICAL, INC.
K781320 07/31/1978 SHORTWAVE THERAPY APPAR. CURAMED 401 GENERAL THERAPHYSICAL, INC.
K781319 07/31/1978 THERAPY APPAR. 422 INTERFERENTIAL GENERAL THERAPHYSICAL, INC.
K781314 07/31/1978 THERAPY UNIT & ELECTRODIAG. GENERAL THERAPHYSICAL, INC.
K781317 07/31/1978 ULTRASONIC THERAPY APPARATUS, 407 GENERAL THERAPHYSICAL, INC.
K781269 07/24/1978 ELISA SYSTME GILFORD INSTRUMENT LABORATORIES, INC.
K781147 07/10/1978 EPILATOR, EASE-MULTI-MODE GREENLEAF-CARTER ENTERPRISES, INC.
K781132 07/03/1978 CHEMLAR HI CHEM, INC.
K781236 07/20/1978 ENTEROTUBE II HOFFMANN-LA ROCHE, INC.
K781142 07/10/1978 DISSCAP HOSPAL MEDICAL CORP.
K781225 07/18/1978 GLOBULIN TEST, HUMAN THYROXINE BINDING HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K781105 07/03/1978 TONOMETER, DIGITON ICAL, INC.
K781220 07/17/1978 ANTI-HUMAN LAMBDA SERUM ICL SCIENTIFIC
K781171 07/13/1978 INFUSION PUMP, PEDIATRIC MODEL 301 IMED CORP.
K781173 07/13/1978 COMPUTER INTERFACE IL 814 INSTRUMENTATION LABORATORY CO.
K781221 07/17/1978 DILUTION KIT, THERMAL, COLD PAC INSTRUMENTATION LABORATORY CO.
K781240 07/20/1978 ENZYMATIC TRIGLYCERIDES REAGENT KIT J.T. BAKER CHEMICAL CO.
K781177 07/06/1978 ULTRASOUND BREAST SCANNING DEVICE LIFE INSTRUMENT CORP.
K781114 07/03/1978 ULTRAMATE 990 LITTON DENTAL PRODUCTS
K781234 07/19/1978 TUBES, LUKENS, TOMAS LUDWIG MEDICAL, INC.
K781230 07/18/1978 GAVAGE ADMIN. SET MCGAW LABORATORIES
K781239 07/20/1978 MYO-STIM MED GENERAL
K781110 07/03/1978 BANDAGE, COMPRESSION, FISTULAID MEDICAL DEVICE LABORATORIES
K781148 07/11/1978 ELECTROSURGICAL PENCIL SYSTEM MEDICAL PLASTICS, INC.
K781218 07/17/1978 ANEMOMETER, NASAL, EXETER MEDIKA CORP.
K781103 07/03/1978 SPECTRASCAN MEDISHIELD, INC.
K781157 07/05/1978 STIMULATOR, NERVE, TRANSCUTANEOUS MEDTECH INTL., INC.
K781252 07/21/1978 GENERATOR, PULSE, MODEL 5997 MEDTRONIC VASCULAR
K781208 07/14/1978 GENERATORS, PULSE, MODELS 5988/5989 MEDTRONIC VASCULAR
K781274 07/24/1978 GAMMA MED II MICK RADIO-NUCLEAR INSTRUMENTS, INC.
K781143 07/10/1978 IMMUNOFLUORESCENCE TEST KIT MICROBIOLOGICAL ASSOC.
K781180 07/14/1978 CLINIRIA T-3 UPTAKE TEST MILES LABORATORIES, INC.
K781181 07/14/1978 CLINIRIA TOTAL T-4 (RIA) TEST MILES LABORATORIES, INC.
K781219 07/17/1978 ECON-O2 MOUNTAIN MEDICAL EQUIPMENT, INC.
K781216 07/17/1978 INFUSION CONTROLLER, PARENTERAL NATIONAL PATENT DEVELOPMENT CORP.
K781154 07/10/1978 SYRINGE, INSULIN, HYPOTIP NATIONAL PATENT DEVELOPMENT CORP.
K781222 07/17/1978 ACCUSCREEN T4 NEOMETRICS, INC.
K781275 07/24/1978 CHLORIDE/CARBON DIOXIDE REAGENT SET NOBEL SCIENTIFIC INDUSTRIES, INC.
K781296 07/27/1978 THYRO-SHURE NUCLEAR MEDICAL LABORATORIES, INC.
K781104 07/03/1978 PLASMA COAGULATION CONT., ABNORMAL ORTHO DIAGNOSTICS, INC.
K781146 07/10/1978 HEMAC LASER HEMATOLOGY SYSTEM ORTHO INSTRUMENTS
K781112 07/03/1978 CAST WEDGE, YANCEY ORTHOPEDIC EQUIPMENT CO., INC.
K781115 07/03/1978 PRINTER, DIGITAL OUTPUT, INC.
K781129 07/05/1978 ACCESSORY TO 4-24 RECORDER OXFORD MEDILOG, INC.
K781130 07/05/1978 ACCESSORY TO ECG ANALYSIS SYS. OXFORD MEDILOG, INC.
K781134 07/06/1978 CATHETER, THERMAL DILUTION FIBEROPTIC OXIMETRIX, INC.
K781209 07/14/1978 MONITOR, OXYGEN, MODEL 3000A OXYAIR ENGINEERING, INC.
K781297 07/27/1978 INTRA-ALERT PAN-TECH RESEARCH, INC.
K781506 07/25/1978 MIC-BIO-PLATE PASCO LABORATORIES, INC.
K781284 07/26/1978 RABBIT ANTIBODY TO HUMAN T3 PCL-RIA, INC.
K781156 07/11/1978 DIALYSIS SYS., PDS 400 & RO 400 PHYSIO-CONTROL CORP.
K781289 07/27/1978 PREAMPLIFIER MODEL 113 PRINCETON APPLIED RESEARCH CORP.
K781290 07/27/1978 SIGNAL AVERAGER MODEL 4202 PRINCETON APPLIED RESEARCH CORP.
K781172 07/13/1978 U-DRAPE, BOUNDARY PROCTER & GAMBLE MFG. CO.
K781224 07/17/1978 METER, FLOW, PEAK PROJECTS IN HEALTH
K781277 07/25/1978 STIMULATOR, NERVE, TRANSCUTANEOUS PSITRON
K781256 07/21/1978 CATHODE RAY TUBE MED. DISPLAY RAE MEDICAL CORP.
K781255 07/21/1978 DIGITAL PANEL METER RAE MEDICAL CORP.
K781113 07/03/1978 MUSCLE STIMULATOR, ELECTRICAL RICH-MAR CORP.
K781167 07/13/1978 STEMPLEX RICH-MAR CORP.
K781101 07/03/1978 ELECTROSURGICAL UNIT 75 RITTER CO.
K781271 07/24/1978 MONITOR, PO2, INTRAVASCULAR ROCHE MEDICAL ELECTRONICS, INC.
K781232 07/21/1978 IPPB ASSEMBLY W/NEBULIZER RTEC
K781231 07/21/1978 OXYGEN SUPPLY TUBE, DISP., PLASTIC RTEC
K781106 07/03/1978 THERMOMETER, EXACTA TEMP S.M.B. CELSIUS CO., INC.
K781127 07/05/1978 CONNECTING TUBE, CONDUCTIVE, SURG. SEAMLESS HOSPITAL PRODUCTS CO.
K781285 07/26/1978 INSULIN RIA KIT SERONO LABORATORIES, INC.
K781223 07/17/1978 OXYGENATOR, BLOOD, INFANT/PEDIATRIC SHILEY, INC.
K781286 07/26/1978 DENTAL X-RAY UNIT SIEMENS CORP.
K781288 07/26/1978 DENTAL X-RAY UNIT HELIODENT 70 SIEMENS CORP.
K781287 07/26/1978 DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH SIEMENS CORP.
K781302 07/28/1978 NEUROSTAT, LLOYD SPEMBLY MEDICAL LTD.
K781301 07/31/1978 WRAP, STERILIZATION STANFORD PROFESSIONAL PRODUCTS
K781281 07/26/1978 CEMENT, DENTAL/CAVITY LINER STAR DENTAL MFG. CO.
K781133 07/06/1978 PC-CALIBRATOR STRECK LABORATORIES, INC.
K781292 07/25/1978 CARDIOPNEUMOGRAPH STREET ELECTRONICS CORP.
K781090 07/03/1978 GENERATOR, CARDIAC PULSE, 250B TELECTRONICS, INC.
K781179 07/14/1978 WRENCH, GEXAGON, DRIVER TELECTRONICS, INC.
K781213 07/10/1978 COMPRESSOR, AIR, MINI-SILENT THE JOHN BUNN CO.
K781293 07/27/1978 RESTORATIVE SYSTEM PROFILE THE S. S. WHITE CO.
K781158 07/05/1978 ALARM UNIT, BATTERY OPERATED THOMPSON RESPIRATION PRODUCTS, INC.
K781161 07/05/1978 RESPIRATOR, BANTAM MODEL THOMPSON RESPIRATION PRODUCTS, INC.
K781160 07/05/1978 VENTILATOR, MINILUNG THOMPSON RESPIRATION PRODUCTS, INC.
K781159 07/05/1978 VENTILATOR, PRESSURE THOMPSON RESPIRATION PRODUCTS, INC.
K781139 07/06/1978 MUSCLE STIMULATOR, ELECTRONIC THOR MEDICAL INSTRUMENTS, INC.
K781174 07/13/1978 CLINAC 12/10 VARIAN ASSOC., INC.
K781189 07/14/1978 FLU VEN 0151 VENOSPITAL, INC.
K781185 07/14/1978 INFUSION SET W/ INJECTION SITE VENOSPITAL, INC.
K781187 07/14/1978 INFUSION SET W/ INJECTION SITE, 23D-W VENOSPITAL, INC.
K781184 07/14/1978 INFUSION SET, VENOTHIN 19 VENOSPITAL, INC.
K781190 07/14/1978 INFUSION SET, VENOTHIN 21 VENOSPITAL, INC.
K781188 07/14/1978 INFUSION SET, VENOTHIN 25 VENOSPITAL, INC.
K781186 07/14/1978 INFUSION, VENOTHIN 23 VENOSPITAL, INC.
K781168 07/13/1978 GENERATOR, PULSE, PACEMAKER VITATRON MEDICAL BV
K781322 07/31/1978 STERILE WET DRESSING PACK W.G. WHITNEY CORP.
K781264 07/24/1978 PAB CONVENIENCE TRAY WATERS ASSOC., INC.
K781257 07/24/1978 VENTILATION TUBE SILI. SHEPPARD TYPE XOMED, INC.
K781260 07/24/1978 VENTILATION TUBE SILICONE PAPARELLA TYPE XOMED, INC.
K781259 07/24/1978 VENTILATION TUBE TEFLON SHEPARD TYPE XOMED, INC.
K781258 07/24/1978 VENTILATION TUBE. SILI. DONALDSON TYPE XOMED, INC.
K781312 07/31/1978 THERMOMETER, MODEL 49TA YELLOW SPRINGS INSTRUMENT CO., INC.


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