Clearance Summary
WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE received FDA 510(k) clearance under submission number K941958, sponsored by Western Dialysis Supplies , Ltd.. 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 1994-09-30.
- Submission: K941958
- Applicant / Sponsor: Western Dialysis Supplies , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1994-09-30
Classification & Regulation
This clearance is catalogued under FDA product code KPO and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.