Clearance Summary
GORE-TEX SAM FACIAL IMPLANT received FDA 510(k) clearance under submission number K946267, sponsored by W. L. Gore & Associates, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1995-03-22.
- Submission: K946267
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3550
- Decision date: 1995-03-22
Classification & Regulation
This clearance is catalogued under FDA product code FWP and 21 CFR 878.3550, within the General, Plastic Surgery review panel as a Class II device.