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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 K040621
Device Name ACELL UBM SURGICAL MESH
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 Received03/09/2004
Decision Date 04/14/2004
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
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