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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K172399
Device Name MicroMatrix
Applicant
Acell, Inc.
6640 Eli Whitney Dr.
Suite 200
Columbia,  MD  21046
Applicant Contact Salman Elmi
Correspondent
Hogan Lovells
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact John Smith
Classification Product Code
KGN  
Date Received08/08/2017
Decision Date 10/06/2017
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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