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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K853392
Device Name MON-A-THERM SUBCUTANEOUS TEMP. SENSOR
Applicant
Mon-A-Therm, Inc.
333 W. Wacker Dr.
Suite 1900
Chicago,  IL  60606
Applicant Contact SHERYL A MARCOUILLE
Correspondent
Mon-A-Therm, Inc.
333 W. Wacker Dr.
Suite 1900
Chicago,  IL  60606
Correspondent Contact SHERYL A MARCOUILLE
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/13/1985
Decision Date 11/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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