Clearance Summary
SAFETY INFUSION SET received FDA 510(k) clearance under submission number K121908, sponsored by Greiner Bio-One North America, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2012-07-25.
- Submission: K121908
- Applicant / Sponsor: Greiner Bio-One North America, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2012-07-25
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.