Clearance Summary
DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES received FDA 510(k) clearance under submission number K010712, sponsored by Molded Products, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2001-09-27.
- Submission: K010712
- Applicant / Sponsor: Molded Products, Inc.
- Clearance pathway: Abbreviated
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2001-09-27
Classification & Regulation
This clearance is catalogued under FDA product code FID and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.