Clearance Summary
PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT received FDA 510(k) clearance under submission number K854084, sponsored by Organon Teknika Corp.. 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 1985-11-08.
- Submission: K854084
- Applicant / Sponsor: Organon Teknika Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1985-11-08
Classification & Regulation
This clearance is catalogued under FDA product code FKL and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.