The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Pen Needle.
| Device ID | K131358 |
| 510k Number | K131358 |
| Device Name: | BD PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BECTON DICKINSON & CO. 1 BECTON DRIVE MC 372 Franklin Lakes, NJ 07417 -1885 |
| Contact | Pasquale Amato |
| Correspondent | Pasquale Amato BECTON DICKINSON & CO. 1 BECTON DRIVE MC 372 Franklin Lakes, NJ 07417 -1885 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-10 |
| Decision Date | 2013-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903282031 | K131358 | 000 |
| 50382903201124 | K131358 | 000 |
| 50382903201193 | K131358 | 000 |
| 50382903201223 | K131358 | 000 |
| 50382903201490 | K131358 | 000 |
| 50382903203678 | K131358 | 000 |
| 00382903205400 | K131358 | 000 |
| 50382903208802 | K131358 | 000 |
| 50382903208819 | K131358 | 000 |
| 50382903208826 | K131358 | 000 |
| 50382903208833 | K131358 | 000 |
| 50382903209816 | K131358 | 000 |
| 50382903209823 | K131358 | 000 |
| 50382903201094 | K131358 | 000 |