Clearance Summary
MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE received FDA 510(k) clearance under submission number K031200, sponsored by Becton, Dickinson & CO. 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 2003-06-24.
- Submission: K031200
- Applicant / Sponsor: Becton, Dickinson & CO
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2003-06-24
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.