Clearance Summary
TOPS DISPOS. INFUSION SET/HEMODIALYSIS received FDA 510(k) clearance under submission number K841119, sponsored by Top Surgical Manufacturers Co.. 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 1984-04-20.
- Submission: K841119
- Applicant / Sponsor: Top Surgical Manufacturers Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 1984-04-20
Classification & Regulation
This clearance is catalogued under FDA product code KNZ and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.