GORE SEAMGUARD Reinforcement— 510(k) K150551

Name: FDA 510(k) clearance K150551
Creator: U.S. Food and Drug Administration
Published: 2015-03-30

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K150551 for GORE SEAMGUARD Reinforcement, Substantially Equivalent on 2015-03-30. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code OXC
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2015-03-04
Decision date: 2015-03-30
Decision: Substantially Equivalent
Clearance type: Special
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.