The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Safeassist.
| Device ID | K161553 |
| 510k Number | K161553 |
| Device Name: | BD SafeAssist |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BECTON, DICKINSON AND COMPANY 1 BECTON DR Franklin Lakes, NJ 07417 |
| Contact | Meriam Youssef |
| Correspondent | Meriam Youssef BECTON, DICKINSON AND COMPANY 1 BECTON DR 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 | 2016-06-06 |
| Decision Date | 2016-07-06 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BD SAFEASSIST 87851948 not registered Live/Pending |
Becton, Dickinson and Company 2018-03-27 |
![]() BD SAFEASSIST 86502505 not registered Dead/Abandoned |
Becton, Dickinson and Company 2015-01-13 |