Clearance Summary
PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM received FDA 510(k) clearance under submission number K993272, sponsored by Pure Water, 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 2000-04-10.
- Submission: K993272
- Applicant / Sponsor: Pure Water, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2000-04-10
Classification & Regulation
This clearance is catalogued under FDA product code FIN and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.