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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 K171225
Device Name Sorbact Wound Dressing-Ribbon Gauze
Applicant
ABIGO Medical AB
Ekonomivagen 5
Askim,  SE SE-436 33
Applicant Contact Annica Corbe
Correspondent
M Squared Associates, Inc.
575 8th Avenue, Suite 1212
New York,  NY  10018
Correspondent Contact Deborah Lavoie Grayeski
Classification Product Code
FRO  
Date Received04/26/2017
Decision Date 08/21/2017
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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