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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 K082459
Device Name ACRYDERM ABSORBENT OXYGEN DRESSING
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 Received08/26/2008
Decision Date 09/19/2008
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
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