Clearance Summary
SAFETY INFUSION SET received FDA 510(k) clearance under submission number K080235, sponsored by Greiner Bio-One Vacuette North America. 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 2008-04-24.
- Submission: K080235
- Applicant / Sponsor: Greiner Bio-One Vacuette North America
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2008-04-24
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.