Clearance Summary
RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS received FDA 510(k) clearance under submission number K883748, sponsored by Kawasumi Laboratories Co., Ltd.. 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 1989-01-31.
- Submission: K883748
- Applicant / Sponsor: Kawasumi Laboratories Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1989-01-31
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.