Clearance Summary
DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS received FDA 510(k) clearance under submission number K082400, sponsored by Culligan Soft Water Service Co.. 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 2009-02-03.
- Submission: K082400
- Applicant / Sponsor: Culligan Soft Water Service Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2009-02-03
Classification & Regulation
This clearance is catalogued under FDA product code FIP and 21 CFR 876.5665, within the Gastroenterology, Urology review panel as a Class II device.