The following data is part of a premarket notification filed by Becton, Dickinson, And Company with the FDA for Bd Soloshot Mini Syringe/ Bd Auto Disable Syringe.
Device ID | K201234 |
510k Number | K201234 |
Device Name: | BD SoloShot Mini Syringe/ BD Auto Disable Syringe |
Classification | Syringe, Piston |
Applicant | Becton, Dickinson, And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
Contact | Avital Merl |
Correspondent | Avital Merl 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 | 2020-05-07 |
Decision Date | 2020-07-15 |