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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 K991818
Device Name ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
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 Received05/27/1999
Decision Date 04/17/2000
Decision Substantially Equivalent (SESE)
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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