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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 K002599
Device Name MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
Applicant
Acrymed, Inc.
12232 SW Garden Pl.
Portland,  OR  97223
Applicant Contact BRUCE GIBBONS
Correspondent
Acrymed, Inc.
12232 SW Garden Pl.
Portland,  OR  97223
Correspondent Contact BRUCE GIBBONS
Classification Product Code
FRO  
Date Received08/21/2000
Decision Date 09/21/2000
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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