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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Recombinant Technology
510(k) Number K211307
Device Name GalaSTITCH Absorbable Monofilament Suture
Applicant
Tepha, Inc.
99 Hayden Ave. Suite 360
Lexington,  MA  02421
Applicant Contact Jodie Giordano
Correspondent
Tepha, Inc.
99 Hayden Ave. Suite 360
Lexington,  MA  02421
Correspondent Contact Jodie Giordano
Regulation Number878.4494
Classification Product Code
NWJ  
Date Received04/29/2021
Decision Date 05/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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