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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 K112409
Device Name MATRISTEM WOUND MATRIX
Applicant
Acell, Inc.
6640 Eli Whitney Dr.
Suite 200
Columbia,  MD  21046
Applicant Contact DEBORAH A BAKER-JANIS
Correspondent
Acell, Inc.
6640 Eli Whitney Dr.
Suite 200
Columbia,  MD  21046
Correspondent Contact DEBORAH A BAKER-JANIS
Classification Product Code
KGN  
Date Received08/22/2011
Decision Date 08/29/2011
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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