510(k) K170386
BD Ultra-Fine Insulin Syringe, BD Ultra-Fine II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine needle and BD Insulin Syringes with Micro-Fine IV Needle by
Becton Dickinson & Company
— Product Code FMF
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2017
- Date Received
- February 8, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type