Clearance Summary
90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET received FDA 510(k) clearance under submission number K903869, sponsored by Fresenius/Delmed, 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 1990-11-20.
- Submission: K903869
- Applicant / Sponsor: Fresenius/Delmed, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 1990-11-20
Classification & Regulation
This clearance is catalogued under FDA product code KDJ and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.