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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, Occlusive
510(k) Number K852091
Device Name ALBA DRY BURN PAD
Applicant
Alba-Waldensian, Inc.
Valdese,  NC  28690
Applicant Contact VICTOR H GARROU
Correspondent
Alba-Waldensian, Inc.
Valdese,  NC  28690
Correspondent Contact VICTOR H GARROU
Regulation Number878.4020
Classification Product Code
NAD  
Date Received05/13/1985
Decision Date 06/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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