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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 K153565
Device Name DONASORB SILVER WOUND DRESSING
Applicant
Virchow Biotech Pvt, Ltd.
5903 SE Milwaukie Ave.
Portland,  OR  97202
Applicant Contact BRUCE GIBBINS
Correspondent
Virchow Biotech Pvt, Ltd.
5903 SE Milwaukie Ave.
Portland,  OR  97202
Correspondent Contact BRUCE GIBBINS
Classification Product Code
FRO  
Date Received12/14/2015
Decision Date 09/22/2016
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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