Clearance Summary
1BD SOLOSHOT IX SYRINGE received FDA 510(k) clearance under submission number K042934, 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 2004-10-28.
- Submission: K042934
- Applicant / Sponsor: Becton, Dickinson & CO
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2004-10-28
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.