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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 K152721
Device Name Cytal Wound Matrix
Applicant
Acell, Inc.
6640 Eli Whitney Dr.
Columbia,  MD  21046
Applicant Contact THOMAS GILBERT
Correspondent
Acell, Inc.
6640 Eli Whitney Dr.
Columbia,  MD  21046
Correspondent Contact THOMAS GILBERT
Classification Product Code
KGN  
Date Received09/21/2015
Decision Date 12/08/2015
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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