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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze / Sponge,Nonresorbable For External Use
510(k) Number K833735
Device Name AN ODOR ABSORBENT 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
Regulation Number878.4014
Classification Product Code
NAB  
Date Received10/25/1983
Decision Date 04/23/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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