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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 K060888
Device Name ACELL POWDER WOUND DRESSING
Applicant
Acell, Inc.
5600 Wisconsin Ave.
Suite,509
Chevy Chase,  MD  20815
Applicant Contact PATSY J TRISLER
Correspondent
Acell, Inc.
5600 Wisconsin Ave.
Suite,509
Chevy Chase,  MD  20815
Correspondent Contact PATSY J TRISLER
Classification Product Code
KGN  
Date Received03/31/2006
Decision Date 06/23/2006
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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