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 | K212015 |
| 510k Number | K212015 |
| 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 | Charlton Foo |
| Correspondent | Charlton Foo Becton Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-28 |
| Decision Date | 2021-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903205740 | K212015 | 000 |
| 50382903205511 | K212015 | 000 |
| 50382903205504 | K212015 | 000 |