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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 K874521
Device Name MODIFIED THERMAL WELL TEMPERATURE SENSOR
Applicant
Mon-A-Therm, Inc.
St. Louis Business Center
500 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact ALAN T BECKMAN
Correspondent
Mon-A-Therm, Inc.
St. Louis Business Center
500 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact ALAN T BECKMAN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/02/1987
Decision Date 01/06/1988
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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