GalaSTITCH Absorbable Monofilament Suture— 510(k) K211307

Substantially Equivalent

Tepha, Inc.

FDA 510(k) clearance K211307 for GalaSTITCH Absorbable Monofilament Suture, Substantially Equivalent on 2021-05-27. Applicant: Tepha, Inc..

Clearance details

Applicant: Tepha, Inc.
Product code: Code NWJ
Advisory panel: General, Plastic Surgery
Date received: 2021-04-29
Decision date: 2021-05-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Lexington, MA, US

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