The following data is part of a premarket notification filed by Becton, Dickinson, And Company with the FDA for Bd Preset Syringe & Bd A-line Syringe.
| Device ID | K202446 |
| 510k Number | K202446 |
| Device Name: | BD Preset Syringe & BD A-Line Syringe |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| 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 | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-26 |
| Decision Date | 2020-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903643165 | K202446 | 000 |
| 00382903643936 | K202446 | 000 |
| 00382903643912 | K202446 | 000 |
| 00382903643905 | K202446 | 000 |
| 00382903643899 | K202446 | 000 |
| 00382903643783 | K202446 | 000 |