Clearance Summary
CAPD DISPOSABLE Y SYSTEM - DY SET received FDA 510(k) clearance under submission number K883393, sponsored by Medionics International , 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 1988-11-03.
- Submission: K883393
- Applicant / Sponsor: Medionics International , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 1988-11-03
Classification & Regulation
This clearance is catalogued under FDA product code KDJ and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.