GORE RESOLUT XT REGENERATIVE MATERIAL— 510(k) K973594

Name: FDA 510(k) clearance K973594
Creator: U.S. Food and Drug Administration
Published: 1997-12-17

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K973594 for GORE RESOLUT XT REGENERATIVE MATERIAL, Substantially Equivalent on 1997-12-17. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 1997-09-22
Decision date: 1997-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, 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.