Clearance Summary
CHIN IMPLANT STYLE I received FDA 510(k) clearance under submission number K945998, sponsored by King & Spalding. 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 1995-02-07.
- Submission: K945998
- Applicant / Sponsor: King & Spalding
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3550
- Decision date: 1995-02-07
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.