The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Flu+ Syringe.
Device ID | K203359 |
510k Number | K203359 |
Device Name: | BD Flu+ Syringe |
Classification | Syringe, Piston |
Applicant | Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
Contact | Nikita Abirami Mahendra Kumar |
Correspondent | Nikita Abirami Mahendra Kumar 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 | 2020-11-16 |
Decision Date | 2021-07-28 |