Clearance Summary
CYCLER W/5 OR 10 HR. FILL/DWELL TIMER received FDA 510(k) clearance under submission number K800496, sponsored by American Medical Products, Inc.. 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 1980-07-21.
- Submission: K800496
- Applicant / Sponsor: American Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 1980-07-21
Classification & Regulation
This clearance is catalogued under FDA product code KPF and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.