PARIETENE MACROPOROUS MESH

Mesh, Surgical, Polymeric

SOFRADIM PRODUCTION

The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietene Macroporous Mesh.

Pre-market Notification Details

Device IDK142091
510k NumberK142091
Device Name:PARIETENE MACROPOROUS MESH
ClassificationMesh, Surgical, Polymeric
Applicant SOFRADIM PRODUCTION 60 MIDDLETOWN AVENUE North Haven,  CT  06473
ContactJennifer Brennan
CorrespondentJennifer Brennan
SOFRADIM PRODUCTION 60 MIDDLETOWN AVENUE North Haven,  CT  06473
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-01
Decision Date2014-10-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10884521213739 K142091 000

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