GalaSTITCH Absorbable Monofilament Suture

Suture, Recombinant Technology

Tepha, Inc.

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

Pre-market Notification Details

Device IDK211307
510k NumberK211307
Device Name:GalaSTITCH Absorbable Monofilament Suture
ClassificationSuture, Recombinant Technology
Applicant Tepha, Inc. 99 Hayden Avenue, Suite 360 Lexington,  MA  02421
ContactJodie Giordano
CorrespondentJodie Giordano
Tepha, Inc. 99 Hayden Avenue, Suite 360 Lexington,  MA  02421
Product CodeNWJ  
CFR Regulation Number878.4494 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-29
Decision Date2021-05-27

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