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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sheet, Burn
510(k) Number K792433
Device Name TEMPORARY BURN SHEET WITH PERFORATED
Applicant
AMERICAN MEDICAL DISPOSABLE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN MEDICAL DISPOSABLE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5180
Classification Product Code
FPY  
Date Received11/28/1979
Decision Date 12/20/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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