BARD VENTRALEX HERNIA PATCH

Mesh, Surgical, Polymeric

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Ventralex Hernia Patch.

Pre-market Notification Details

Device IDK132441
510k NumberK132441
Device Name:BARD VENTRALEX HERNIA PATCH
ClassificationMesh, Surgical, Polymeric
Applicant C.R. BARD, INC. 100 CROSSINGS BLVD. Warwick,  RI  02886
ContactMariya Buharin
CorrespondentMariya Buharin
C.R. BARD, INC. 100 CROSSINGS BLVD. Warwick,  RI  02886
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-06
Decision Date2013-12-13
Summary:summary

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