The following data is part of a premarket notification filed by Becton Dickinson And Company with the FDA for Bd Insulin Syringe.
| Device ID | K190054 |
| 510k Number | K190054 |
| Device Name: | BD Insulin Syringe |
| Classification | Syringe, Piston |
| Applicant | Becton Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Contact | Meriam Youssef |
| Correspondent | Meriam Youssef Becton Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-11 |
| Decision Date | 2019-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903284400 | K190054 | 000 |
| 50382903285094 | K190054 | 000 |
| 50382909288563 | K190054 | 000 |
| 50382909288532 | K190054 | 000 |
| 50382909288549 | K190054 | 000 |
| 50382909288556 | K190054 | 000 |
| 50382909288518 | K190054 | 000 |
| 50382909288501 | K190054 | 000 |
| 50382909288570 | K190054 | 000 |