Clearance Summary
MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL. received FDA 510(k) clearance under submission number K873887, sponsored by W.R. Grace & Co.-Conn.. 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 1987-12-09.
- Submission: K873887
- Applicant / Sponsor: W.R. Grace & Co.-Conn.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5860
- Decision date: 1987-12-09
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.