Clearance Summary
UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205F) received FDA 510(k) clearance under submission number K861518, sponsored by Jufrey Multimed Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1986-05-27.
- Submission: K861518
- Applicant / Sponsor: Jufrey Multimed Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1986-05-27
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.