Clearance Summary
WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS received FDA 510(k) clearance under submission number K042797, sponsored by Gambro Renal Products. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2005-03-09.
- Submission: K042797
- Applicant / Sponsor: Gambro Renal Products
- Clearance pathway: Abbreviated
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2005-03-09
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.