COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM

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 Composix L/p Mesh With Echo Ps Positioning System.

Pre-market Notification Details

Device IDK102766
510k NumberK102766
Device Name:COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
ClassificationMesh, Surgical, Polymeric
Applicant C.R. BARD INC 100 CROSSINGS BOULEVARD Warwick,  RI  02886
ContactKeti Sino
CorrespondentKeti Sino
C.R. BARD INC 100 CROSSINGS BOULEVARD Warwick,  RI  02886
Product CodeFTL  
Subsequent Product CodeGCJ
Subsequent Product CodeOQL
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-24
Decision Date2010-12-16
Summary:summary

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