Phasix ST Mesh

Mesh, Surgical, Absorbable, Abdominal Hernia

C. R. Bard Inc

The following data is part of a premarket notification filed by C. R. Bard Inc with the FDA for Phasix St Mesh.

Pre-market Notification Details

Device IDK173143
510k NumberK173143
Device Name:Phasix ST Mesh
ClassificationMesh, Surgical, Absorbable, Abdominal Hernia
Applicant C. R. Bard Inc 100 Crossings Boulevard Warwick,  RI  02886
ContactTony John
CorrespondentTony John
C. R. Bard Inc 100 Crossings Boulevard Warwick,  RI  02886
Product CodeOWT  
Subsequent Product CodeFTL
Subsequent Product CodeOOD
Subsequent Product CodeOWZ
Subsequent Product CodeOXC
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2018-04-25
Summary:summary

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