Clearance Summary
BIOPSY TRAY I & II received FDA 510(k) clearance under submission number K854095, 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 1985-11-25.
- Submission: K854095
- Applicant / Sponsor: North Coast Medi-Tek
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 1985-11-25
Classification & Regulation
This clearance is catalogued under FDA product code LRO and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.