Clearance Summary
PRISM MEDICAL CUSTOM DIALYSIS KIT received FDA 510(k) clearance under submission number K941803, sponsored by Medical Device Support Services. 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 1995-01-30.
- Submission: K941803
- Applicant / Sponsor: Medical Device Support Services
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1995-01-30
Classification & Regulation
This clearance is catalogued under FDA product code KOC and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.