Clearance Summary
AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET received FDA 510(k) clearance under submission number K090117, sponsored by Autosafe-Reflex, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2009-09-29.
- Submission: K090117
- Applicant / Sponsor: Autosafe-Reflex, Inc.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2009-09-29
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.