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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 K031332
Device Name BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH
Original Applicant
C.R. BARD, INC.
8195 industrial blvd.
covington,  GA  30014
Original Contact terrina wilder
Regulation Number878.3300
Classification Product Code
FTM  
Date Received04/29/2003
Decision Date 05/15/2003
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
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