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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 K792432
Device Name TEMPORARY BURN SHEET WITH PERFORATED
Applicant
AMERICAN MEDICAL DISPOSABLE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AMERICAN MEDICAL DISPOSABLE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
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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