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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Electronic, Clinical
510(k) Number K821555
Device Name EXACON THERMOMETER SYSTEM 8000
Applicant
SAT EXPORT ENGINEERING & TRADING
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SAT EXPORT ENGINEERING & TRADING
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/25/1982
Decision Date 08/16/1982
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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