SurgiLattice Scaffold

Surgical Film

Tepha, Inc.

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

Pre-market Notification Details

Device IDK202425
510k NumberK202425
Device Name:SurgiLattice Scaffold
ClassificationSurgical Film
Applicant Tepha, Inc. 99 Hayden Avenue, Suite 360 Lexington,  MA  02421
ContactKavetha Ram
CorrespondentConnie Garrison
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 Received2020-08-25
Decision Date2021-08-19

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.