Clearance Summary
RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY received FDA 510(k) clearance under submission number K870417, sponsored by North Coast Medi-Tek. 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 1987-03-05.
- Submission: K870417
- Applicant / Sponsor: North Coast Medi-Tek
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1987-03-05
Classification & Regulation
This clearance is catalogued under FDA product code FSM and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.