Clearance Summary
DIANEAL SOLUTION EXCHANGE DEVICE #5C4193 received FDA 510(k) clearance under submission number K822361, sponsored by Travenol Laboratories, S.A.. 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 1982-08-16.
- Submission: K822361
- Applicant / Sponsor: Travenol Laboratories, S.A.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 1982-08-16
Classification & Regulation
This clearance is catalogued under FDA product code FKX and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.