Clearance Summary
AMG + MED LANCET received FDA 510(k) clearance under submission number K870017, sponsored by Can-Am Surgical Corp.. 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 1987-01-21.
- Submission: K870017
- Applicant / Sponsor: Can-Am Surgical Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4850
- Decision date: 1987-01-21
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.