TEPHAFLEX MESH

Surgical Film

TEPHA, INC.

The following data is part of a premarket notification filed by Tepha, Inc. with the FDA for Tephaflex Mesh.

Pre-market Notification Details

Device IDK111946
510k NumberK111946
Device Name:TEPHAFLEX MESH
ClassificationSurgical Film
Applicant TEPHA, INC. 99 HAYDEN AVENUE, SUITE 360 Lexington,  MA  02421
ContactMary P Legraw
CorrespondentMary P Legraw
TEPHA, INC. 99 HAYDEN AVENUE, SUITE 360 Lexington,  MA  02421
Product CodeOOD  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-08
Decision Date2011-09-26
Summary:summary

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