The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Insulin Syringe (0.3ml).
| Device ID | K212499 |
| 510k Number | K212499 |
| Device Name: | BD Insulin Syringe (0.3mL) |
| Classification | Syringe, Piston |
| Applicant | Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Contact | Mark William |
| Correspondent | Mark William 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 | 2021-08-09 |
| Decision Date | 2022-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10382903247025 | K212499 | 000 |
| 50382909288587 | K212499 | 000 |
| 50382909288570 | K212499 | 000 |
| 50382909288525 | K212499 | 000 |
| 50382909288556 | K212499 | 000 |