Clearance Summary
GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER received FDA 510(k) clearance under submission number K871108, sponsored by Gambro, 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 1987-05-15.
- Submission: K871108
- Applicant / Sponsor: Gambro, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5860
- Decision date: 1987-05-15
Classification & Regulation
This clearance is catalogued under FDA product code KDI and 21 CFR 876.5860, within the Gastroenterology, Urology review panel as a Class II device.