Clearance Summary
DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS received FDA 510(k) clearance under submission number K123282, sponsored by Ultrapure & Industrial Services, LLC. 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 2013-04-25.
- Submission: K123282
- Applicant / Sponsor: Ultrapure & Industrial Services, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2013-04-25
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.