The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Eclipse Hypodermic Needle.
| Device ID | K161170 |
| 510k Number | K161170 |
| Device Name: | BD Eclipse Hypodermic Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Contact | Priyanka Apte |
| Correspondent | Priyanka Apte Becton, Dickinson And Company 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 | 2016-04-26 |
| Decision Date | 2016-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382903057772 | K161170 | 000 |
| 30382903033066 | K161170 | 000 |
| 30382903033073 | K161170 | 000 |
| 00382903057122 | K161170 | 000 |
| 00382903058266 | K161170 | 000 |
| 30382903058298 | K161170 | 000 |
| 00382903058372 | K161170 | 000 |
| 00382903058389 | K161170 | 000 |
| 50382903033046 | K161170 | 000 |
| 50382903033213 | K161170 | 000 |