XENMATRIX SURGICAL GRAFT

Mesh, Surgical

C.R. BARD

The following data is part of a premarket notification filed by C.r. Bard with the FDA for Xenmatrix Surgical Graft.

Pre-market Notification Details

Device IDK140501
510k NumberK140501
Device Name:XENMATRIX SURGICAL GRAFT
ClassificationMesh, Surgical
Applicant C.R. BARD 100 CROSSINGS BOULEVARD Warwick,  RI  02886
ContactGina Cassidy
CorrespondentGina Cassidy
C.R. BARD 100 CROSSINGS BOULEVARD Warwick,  RI  02886
Product CodeFTM  
Subsequent Product CodeOWV
Subsequent Product CodeOXH
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-27
Decision Date2014-04-28
Summary:summary

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