GORE-TEX SAM FACIAL IMPLANT— 510(k) K946267

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K946267 for GORE-TEX SAM FACIAL IMPLANT, Substantially Equivalent on 1995-03-22. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code FWP
Advisory panel: General, Plastic Surgery
Date received: 1994-12-23
Decision date: 1995-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

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