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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 K880639
Device Name ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE
Applicant
Human Technologies, Inc.
300 Third Ave. N.
St Petersburg,  FL  33701
Applicant Contact MICHAEL HAZEL
Correspondent
Human Technologies, Inc.
300 Third Ave. N.
St Petersburg,  FL  33701
Correspondent Contact MICHAEL HAZEL
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/16/1988
Decision Date 11/02/1988
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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