The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Modification To Bd Eclipse Hypodermic Needle.
| Device ID | K043397 |
| 510k Number | K043397 |
| Device Name: | MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BECTON DICKINSON & CO. 1 Becton Drive Franklin Lakes, NJ 07417 |
| Contact | Pasquale Amato |
| Correspondent | Pasquale Amato BECTON DICKINSON & CO. 1 Becton Drive Franklin Lakes, NJ 07417 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-10 |
| Decision Date | 2004-12-29 |
| Summary: | summary |