Clearance Summary
CLINIFEEDING SYSTEM 1 received FDA 510(k) clearance under submission number K791758, sponsored by Roussel (Canada) , Ltd.. 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 1979-10-26.
- Submission: K791758
- Applicant / Sponsor: Roussel (Canada) , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1979-10-26
Classification & Regulation
This clearance is catalogued under FDA product code KNT and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.