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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K943781
Device Name ACRYDERM ADVANCED WOUND DRESSING
Applicant
Acrymed, Inc.
31 Walking Woods Dr.
Lake Oswego,  OR  97035
Applicant Contact BRUCE L GIBBINS, PH.D
Correspondent
Acrymed, Inc.
31 Walking Woods Dr.
Lake Oswego,  OR  97035
Correspondent Contact BRUCE L GIBBINS, PH.D
Regulation Number880.5090
Classification Product Code
KMF  
Date Received08/03/1994
Decision Date 10/04/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
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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