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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K833733
Device Name NON - ADHERENT BANDAGE
Applicant
American Medical Disposable, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Medical Disposable, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
FRO  
Date Received10/25/1983
Decision Date 12/27/1983
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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