Clearance Summary
COLORECTAL DILATOR received FDA 510(k) clearance under submission number K830354, sponsored by Cleveland Medical Supply & Services. 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 1983-05-27.
- Submission: K830354
- Applicant / Sponsor: Cleveland Medical Supply & Services
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5450
- Decision date: 1983-05-27
Classification & Regulation
This clearance is catalogued under FDA product code FFP and 21 CFR 876.5450, within the Gastroenterology, Urology review panel as a Class I device.