Clearance Summary
IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT received FDA 510(k) clearance under submission number K942420, 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 1994-08-08.
- Submission: K942420
- Applicant / Sponsor: King & Spalding
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3550
- Decision date: 1994-08-08
Classification & Regulation
This clearance is catalogued under FDA product code LZK and 21 CFR 878.3550, within the General, Plastic Surgery review panel as a Class II device.