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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K041140
Device Name ACELL UBM SURGICAL MESH ML AND MLPLUS
Applicant
Acell, Inc.
5610 Wisconsin Ave., #304
Chevy Chase,  MD  20815
Applicant Contact PATSY J TRISLER
Correspondent
Acell, Inc.
5610 Wisconsin Ave., #304
Chevy Chase,  MD  20815
Correspondent Contact PATSY J TRISLER
Regulation Number878.3300
Classification Product Code
FTM  
Date Received04/30/2004
Decision Date 07/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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