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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 K830839
Device Name AMER. 400 SERIES TEMP. PROBES-RECTALL
Applicant
American Pharmaseal Div. Ahsc
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Pharmaseal Div. Ahsc
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/16/1983
Decision Date 04/06/1983
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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