DynaMesh-POSTERIOR

Mesh, Surgical, Polymeric

FEG Textiltechnik Forschungs- Und Entwicklungsgesellschaft

The following data is part of a premarket notification filed by Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft with the FDA for Dynamesh-posterior.

Pre-market Notification Details

Device IDK182087
510k NumberK182087
Device Name:DynaMesh-POSTERIOR
ClassificationMesh, Surgical, Polymeric
Applicant FEG Textiltechnik Forschungs- Und Entwicklungsgesellschaft mbH Prager Ring 70 Aachen,  DE D-52070
ContactStefan Schneemelcher
CorrespondentNeil R. Armstrong
MeddiQuest Regulatory Affairs Ltd Unit 73B Hebron Industrial Estate Kilkenny,  IE R95 Crk2
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-02
Decision Date2018-10-31
Summary:summary

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