GORE REVOX THYROPLASTY IMPLANT— 510(k) K983525

Name: FDA 510(k) clearance K983525
Creator: U.S. Food and Drug Administration
Published: 1998-12-10

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K983525 for GORE REVOX THYROPLASTY IMPLANT, Substantially Equivalent on 1998-12-10. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code MIX
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 1998-10-08
Decision date: 1998-12-10
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.