The following data is part of a premarket notification filed by Becton, Dickinson And Co. with the FDA for Bd Pen Needle.
| Device ID | K100005 |
| 510k Number | K100005 |
| Device Name: | BD PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BECTON, DICKINSON AND CO. 1 BECTON DRIVE MC 372 Franklin Lakes, NJ 07417 -0741 |
| Contact | James Haynes |
| Correspondent | James Haynes BECTON, DICKINSON AND CO. 1 BECTON DRIVE MC 372 Franklin Lakes, NJ 07417 -0741 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-04 |
| Decision Date | 2010-04-15 |
| Summary: | summary |