Clearance Summary
GREENLIGHT 300 received FDA 510(k) clearance under submission number K040410, sponsored by A C Cossor & Son (Surgical) Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-05-05.
- Submission: K040410
- Applicant / Sponsor: A C Cossor & Son (Surgical) Limited
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2004-05-05
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.