Clearance Summary
RINSE MACHINE KR-4 KIDNEY RINSE-4 received FDA 510(k) clearance under submission number K850799, sponsored by Medical Technologies International, 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 1985-07-29.
- Submission: K850799
- Applicant / Sponsor: Medical Technologies International, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1985-07-29
Classification & Regulation
This clearance is catalogued under FDA product code LIF and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.