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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 K061232
Device Name ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006
Applicant
Acrymed, Inc.
9560 SW Nimbus Ave.
Beaverton,  OR  97008
Applicant Contact BRUCE GIBBINS
Correspondent
Acrymed, Inc.
9560 SW Nimbus Ave.
Beaverton,  OR  97008
Correspondent Contact BRUCE GIBBINS
Classification Product Code
FRO  
Date Received05/02/2006
Decision Date 10/06/2006
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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