ECHO 2.0 LAP SYSTEM With VENTRALIGHT ST MESH

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 Echo 2.0 Lap System With Ventralight St Mesh.

Pre-market Notification Details

Device IDK143743
510k NumberK143743
Device Name:ECHO 2.0 LAP SYSTEM With VENTRALIGHT ST MESH
ClassificationMesh, Surgical, Polymeric
Applicant C.R. Bard Inc. 100 Crossings Blvd. Warwick,  RI  02886
ContactFelicia Ruley
CorrespondentAndrew Harrell
C.R. Bard Inc. 100 Crossings Blvd. Warwick,  RI  02886
Product CodeFTL  
Subsequent Product CodeGCJ
Subsequent Product CodeORQ
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-31
Decision Date2015-09-18
Summary:summary

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