The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd U-500 Insulin Syringe.
| Device ID | K151870 |
| 510k Number | K151870 |
| Device Name: | BD U-500 INSULIN SYRINGE |
| Classification | Syringe, Piston |
| Applicant | BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes, NJ 07666 |
| Contact | Luisa F. Metrio |
| Correspondent | Matthew F. Trachtenberg BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes, NJ 07666 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-09 |
| Decision Date | 2016-07-08 |
| Summary: | summary |