Clearance Summary
MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS received FDA 510(k) clearance under submission number K945559, sponsored by Mar Cor Services, 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 1996-05-28.
- Submission: K945559
- Applicant / Sponsor: Mar Cor Services, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 1996-05-28
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.