Clearance Summary
GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER received FDA 510(k) clearance under submission number K890111, 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 1989-02-08.
- Submission: K890111
- Applicant / Sponsor: Gambro, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1989-02-08
Classification & Regulation
This clearance is catalogued under FDA product code FJI and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.