Clearance Summary
GOLDFINGER DEVICE received FDA 510(k) clearance under submission number K001162, sponsored by Mali-Tech , Ltd.. 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 2000-08-09.
- Submission: K001162
- Applicant / Sponsor: Mali-Tech , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4850
- Decision date: 2000-08-09
Classification & Regulation
This clearance is catalogued under FDA product code FMK and 21 CFR 878.4850, within the General, Plastic Surgery review panel as a Class II device.