Clearance Summary
GORETEX SAM FACIAL IMPLANT received FDA 510(k) clearance under submission number K942280, 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 1994-07-28.
- Submission: K942280
- 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: 1994-07-28
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.