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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 K153674
Device Name Sorbact Foam Gentle Border, Sorbact Superabsorbent
Applicant
Abigo Medical AB
Ekonomivagen 5
Askim,  SE SE-436 33
Applicant Contact Annica Corbe
Correspondent
Msquared Associates, Inc.
575 8th Ave.
Suite 1212
New York,  NY  10018
Correspondent Contact Deborah Lavoie Grayeski
Classification Product Code
FRO  
Date Received12/21/2015
Decision Date 07/01/2016
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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