Clearance Summary
HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H received FDA 510(k) clearance under submission number K895759, sponsored by National Medical Care, Medical Products Div., 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 1989-11-08.
- Submission: K895759
- Applicant / Sponsor: National Medical Care, Medical Products Div., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5860
- Decision date: 1989-11-08
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.