GORE-TEX FACIAL IMPLANT— 510(k) K933367

Substantially Equivalent - Subject to Tracking Reg.

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K933367 for GORE-TEX FACIAL IMPLANT, Substantially Equivalent - Subject to Tracking Reg. on 1994-07-28. 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: 1993-07-09
Decision date: 1994-07-28
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Flagstaff, AZ, US

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