GORETEX SAM FACIAL IMPLANT— 510(k) K942280

Name: FDA 510(k) clearance K942280
Creator: U.S. Food and Drug Administration
Published: 1994-07-28

Substantially Equivalent - Subject to Tracking Reg.

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K942280 for GORETEX SAM FACIAL IMPLANT, Substantially Equivalent - Subject to Tracking Reg. on 1994-07-28. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code FWP
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 1994-05-10
Decision date: 1994-07-28
Decision: Substantially Equivalent - Subject to Tracking Reg.
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.