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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 K012116
Device Name ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING
Applicant
Acrymed, Inc.
12232 SW Garden Pl.
Portland,  OR  97223
Applicant Contact BRUCE GIBBINS
Correspondent
Acrymed, Inc.
12232 SW Garden Pl.
Portland,  OR  97223
Correspondent Contact BRUCE GIBBINS
Classification Product Code
FRO  
Date Received07/06/2001
Decision Date 09/12/2001
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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