Clearance Summary
CMR 300, ROWATER TREATMENT UNIT received FDA 510(k) clearance under submission number K802474, sponsored by U-Marc, 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 1980-12-15.
- Submission: K802474
- Applicant / Sponsor: U-Marc, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 1980-12-15
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.