PARIETEX COMPOSITE MONO PM MESH

Mesh, Surgical, Polymeric

SOFRADIM PRODUCTION

The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietex Composite Mono Pm Mesh.

Pre-market Notification Details

Device IDK081126
510k NumberK081126
Device Name:PARIETEX COMPOSITE MONO PM MESH
ClassificationMesh, Surgical, Polymeric
Applicant SOFRADIM PRODUCTION 60 MIDDLETOWN AVENUE North Haven,  CT  06473
ContactSharon Alexander
CorrespondentSharon Alexander
SOFRADIM PRODUCTION 60 MIDDLETOWN AVENUE North Haven,  CT  06473
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2008-04-21
Decision Date2008-08-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521177789 K081126 000
10884521177772 K081126 000
10884521177765 K081126 000
10884521177758 K081126 000

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