Clearance Summary
A O FIBER OPTIC ILLUMINATOR, 1185B received FDA 510(k) clearance under submission number K821754, sponsored by Warner-Lambert Co.. 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 1982-06-24.
- Submission: K821754
- Applicant / Sponsor: Warner-Lambert Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1982-06-24
Classification & Regulation
This clearance is catalogued under FDA product code FCR and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.