The following data is part of a premarket notification filed by Becton Dickinson And Company (bd) with the FDA for Bd Pen Needle.
| Device ID | K110105 |
| 510k Number | K110105 |
| Device Name: | BD PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BECTON DICKINSON AND COMPANY (BD) 1 BECTON DRIVE. MC372 Franklin Lakes, NJ 07417 -1885 |
| Contact | Pasquale Amato |
| Correspondent | Pasquale Amato BECTON DICKINSON AND COMPANY (BD) 1 BECTON DRIVE. MC372 Franklin Lakes, NJ 07417 -1885 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-13 |
| Decision Date | 2011-04-28 |
| Summary: | summary |