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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
Original Applicant
ACELL, INC
5610 wisconsin ave
#304
chevy chase,  MD  20815
Original Contact patsy j trisler
Regulation Number878.3300
Classification Product Code
FTM  
Date Received04/30/2004
Decision Date 07/07/2004
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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