GORE-TEX REGENERATIVE MATERIAL— 510(k) K922627

Name: FDA 510(k) clearance K922627
Creator: U.S. Food and Drug Administration
Published: 1994-06-10

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K922627 for GORE-TEX REGENERATIVE MATERIAL, Substantially Equivalent on 1994-06-10. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code NPK
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 1992-06-03
Decision date: 1994-06-10
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.