HP Tissue Matrix

Mesh, Surgical

LifeCell Corporation

The following data is part of a premarket notification filed by Lifecell Corporation with the FDA for Hp Tissue Matrix.

Pre-market Notification Details

Device IDK142326
510k NumberK142326
Device Name:HP Tissue Matrix
ClassificationMesh, Surgical
Applicant LifeCell Corporation One Millennium Way Branchburg,  NJ  08876
ContactMira Leiwant
CorrespondentMira Leiwant
LifeCell Corporation One Millennium Way Branchburg,  NJ  08876
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-20
Decision Date2014-12-23
Summary:summary

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