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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Temperature, Forehead, Liquid Crystal
510(k) Number K790532
Device Name FEVER TESTER
Applicant
MADDAK, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MADDAK, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.2200
Classification Product Code
KPD  
Date Received03/15/1979
Decision Date 05/29/1979
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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