TEPHAFLEX ABSORBABLE SUTURE— 510(k) K081099

Substantially Equivalent

Tepha, Inc.

FDA 510(k) clearance K081099 for TEPHAFLEX ABSORBABLE SUTURE, Substantially Equivalent on 2008-07-15. Applicant: Tepha, Inc.. Device class: 2.

Clearance details

Applicant: Tepha, Inc.
Product code: Code NWJ
Device class: Class 2
Regulation: 21 CFR 878.4494
Advisory panel: General, Plastic Surgery
Date received: 2008-04-17
Decision date: 2008-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.