GORE ENFORM Biomaterial— 510(k) K173333

Name: FDA 510(k) clearance K173333
Creator: U.S. Food and Drug Administration
Published: 2018-04-05

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K173333 for GORE ENFORM Biomaterial, Substantially Equivalent on 2018-04-05. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code OXF
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2017-10-23
Decision date: 2018-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, 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.