Clearance Summary
GAMBRO LUNDIA 94-500 DIALYZER received FDA 510(k) clearance under submission number K945746, sponsored by Cobe Renal Care, 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 1995-09-08.
- Submission: K945746
- Applicant / Sponsor: Cobe Renal Care, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1995-09-08
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.