The following data is part of a premarket notification filed by Becton Dickinson And Company with the FDA for Bd Epilor Syringe.
Device ID | K210983 |
510k Number | K210983 |
Device Name: | BD Epilor Syringe |
Classification | Anesthesia Conduction Kit |
Applicant | Becton Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
Contact | Huwien Yang |
Correspondent | Huwien Yang Becton Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-04-01 |
Decision Date | 2022-05-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50382904052923 | K210983 | 000 |
50382904052916 | K210983 | 000 |