Clearance Summary
DOTOLO COLON HYDROTHERAPY INSTRUMENT received FDA 510(k) clearance under submission number K870534, sponsored by Dotolo Research Corp. C/O Keller and Heckman. 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 1987-06-18.
- Submission: K870534
- Applicant / Sponsor: Dotolo Research Corp. C/O Keller and Heckman
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5220
- Decision date: 1987-06-18
Classification & Regulation
This clearance is catalogued under FDA product code KPL and 21 CFR 876.5220, within the Gastroenterology, Urology review panel as a Class II device.