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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, polymeric
510(k) Number K091659
Device Name BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
Applicant
C.R. BARD, INC.
100 CROSSINGS BLVD.
warwick,  RI  02886
Applicant Contact gail dow
Correspondent
C.R. BARD, INC.
100 CROSSINGS BLVD.
warwick,  RI  02886
Correspondent Contact gail dow
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/09/2009
Decision Date 08/03/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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