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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 K884422
Device Name POLYGLUCOSE POWDER
Applicant
Anthony N Silvetti, M.D., S.C.
4660 Kenmore Ave.
Suite 1018
Alexandria,  VA  22304
Applicant Contact KEVNEY J O'CONNOR
Correspondent
Anthony N Silvetti, M.D., S.C.
4660 Kenmore Ave.
Suite 1018
Alexandria,  VA  22304
Correspondent Contact KEVNEY J O'CONNOR
Classification Product Code
FRO  
Date Received10/22/1988
Decision Date 02/22/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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