Clearance Summary
HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS received FDA 510(k) clearance under submission number K893991, sponsored by P & A 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 1990-01-11.
- Submission: K893991
- Applicant / Sponsor: P & A Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1990-01-11
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.