Clearance Summary
MAR COR SERVICES SEMPER PURE RO MACHINE received FDA 510(k) clearance under submission number K003877, sponsored by Mar Cor Services, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2001-06-22.
- Submission: K003877
- Applicant / Sponsor: Mar Cor Services, Inc.
- Clearance pathway: Abbreviated
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2001-06-22
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.