OVINE TISSUE MATRIX(OTM)

Mesh, Surgical

TELA BIO, INC.

The following data is part of a premarket notification filed by Tela Bio, Inc. with the FDA for Ovine Tissue Matrix(otm).

Pre-market Notification Details

Device IDK141053
510k NumberK141053
Device Name:OVINE TISSUE MATRIX(OTM)
ClassificationMesh, Surgical
Applicant TELA BIO, INC. 1 GREAT VALLEY PARKWAY, SUITE 24 Malven,  PA  19355
ContactDonna Stauffer
CorrespondentDonna Stauffer
TELA BIO, INC. 1 GREAT VALLEY PARKWAY, SUITE 24 Malven,  PA  19355
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-24
Decision Date2014-12-11
Summary:summary

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