Clearance Summary
COLON IRRIGATION DEV.,COLON-A-SUN COLONI received FDA 510(k) clearance under submission number K770300, sponsored by Sun Product Dist., 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 1977-03-30.
- Submission: K770300
- Applicant / Sponsor: Sun Product Dist., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5210
- Decision date: 1977-03-30
Classification & Regulation
This clearance is catalogued under FDA product code FCE and 21 CFR 876.5210, within the Gastroenterology, Urology review panel as a Class I device.