The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Pen Needle.
| Device ID | K162516 |
| 510k Number | K162516 |
| Device Name: | BD Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes, NJ 07417 |
| Contact | Meriam Youssef |
| Correspondent | Meriam Youssef 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 | 2016-09-09 |
| Decision Date | 2016-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903206174 | K162516 | 000 |
| 50382903206181 | K162516 | 000 |
| 60840164519442 | K162516 | 000 |
| 60378206131012 | K162516 | 000 |
| 60378206130015 | K162516 | 000 |
| 60378206129019 | K162516 | 000 |