Clearance Summary
PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 received FDA 510(k) clearance under submission number K964586, sponsored by Iba/Griffith. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1997-01-17.
- Submission: K964586
- Applicant / Sponsor: Iba/Griffith
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1997-01-17
Classification & Regulation
This clearance is catalogued under FDA product code FCW and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.