The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Nano 2nd Gen Pen Needle.
Device ID | K213156 |
510k Number | K213156 |
Device Name: | BD Nano 2nd Gen Pen Needle |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
Contact | Mark William |
Correspondent | Mark William Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-20 |
Decision Date | 2021-12-08 |