The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Eclipse Needle With Smartslip Technology.
| Device ID | K100209 |
| 510k Number | K100209 |
| Device Name: | BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BECTON DICKINSON & CO. 1 BECTON DRIVE MC237 Franklin Lakes, NJ 07417 |
| Contact | Pasquale Amato |
| Correspondent | Pasquale Amato BECTON DICKINSON & CO. 1 BECTON DRIVE MC237 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 | 2010-01-25 |
| Decision Date | 2010-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382903057765 | K100209 | 000 |
| 30382903058878 | K100209 | 000 |
| 50382903058926 | K100209 | 000 |
| 50382903058957 | K100209 | 000 |
| 30382903024361 | K100209 | 000 |
| 30382903057604 | K100209 | 000 |
| 30382903058861 | K100209 | 000 |
| 30382903058885 | K100209 | 000 |
| 30382903058892 | K100209 | 000 |
| 30382903058915 | K100209 | 000 |
| 30382903058946 | K100209 | 000 |
| 30382903058991 | K100209 | 000 |
| 30382903057758 | K100209 | 000 |
| 30382903057703 | K100209 | 000 |