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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 K850241
Device Name ALBA HEALTH CARE NON-ADHERING DRESSING
Applicant
Alba Health Care
Post Office Box 100
Valdese,  NC  28690
Applicant Contact VICTOR H GARROU
Correspondent
Alba Health Care
Post Office Box 100
Valdese,  NC  28690
Correspondent Contact VICTOR H GARROU
Classification Product Code
FRO  
Date Received01/22/1985
Decision Date 03/12/1985
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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