The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd 1ml Luer-lok Hypodermic Syringe, Bd 1 Ml Luer-lok Hypodermic Syringe With Bd Hypodermic Needle Or Bd Eclipse Hypodermic Needle, Bd 1ml Luer-lok Insulin Syringe.
| Device ID | K162081 |
| 510k Number | K162081 |
| Device Name: | BD 1ml Luer-lok Hypodermic Syringe, BD 1 ML Luer-Lok Hypodermic Syringe With BD Hypodermic Needle Or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe |
| Classification | Syringe, Piston |
| Applicant | Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Contact | Murtaza Rana |
| Correspondent | Murtaza Rana Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-27 |
| Decision Date | 2016-12-19 |
| Summary: | summary |