VENTRALEX ST 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 Ventralex St Hernia Patch.

Pre-market Notification Details

Device IDK101928
510k NumberK101928
Device Name:VENTRALEX ST HERNIA PATCH
ClassificationMesh, Surgical, Polymeric
Applicant C.R. BARD, INC. 100 CROSSINGS BOULEVARD Warwick,  RI  02886
ContactMichelle Godin
CorrespondentMichelle Godin
C.R. BARD, INC. 100 CROSSINGS BOULEVARD Warwick,  RI  02886
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-09
Decision Date2011-03-23
Summary:summary

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