TEPHAFLEX ABSORBABLE SUTURE

Suture, Recombinant Technology

TEPHA, INC.

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

Pre-market Notification Details

Device IDK082178
510k NumberK082178
Device Name:TEPHAFLEX ABSORBABLE SUTURE
ClassificationSuture, Recombinant Technology
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 CodeNWJ  
CFR Regulation Number878.4494 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-01
Decision Date2008-10-30
Summary:summary

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