Clearance Summary
HEMODIAL CONCENTRATE MIXING APPARATUS received FDA 510(k) clearance under submission number K842225, sponsored by Lmf Medical Research & Manufacturing, 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 1984-10-02.
- Submission: K842225
- Applicant / Sponsor: Lmf Medical Research & Manufacturing, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1984-10-02
Classification & Regulation
This clearance is catalogued under FDA product code FKQ and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.