The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for 0.9% Sodium Chloride Injection Usp Bd Posiflush Flush Syringe, Sf Flush Syringe.
| Device ID | K121050 |
| 510k Number | K121050 |
| Device Name: | 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE |
| Classification | Saline, Vascular Access Flush |
| Applicant | BECTON DICKINSON & CO. 1 Becton Drive Franklin Lakes, NJ 07417 |
| Contact | John Roberts |
| Correspondent | John Roberts BECTON DICKINSON & CO. 1 Becton Drive Franklin Lakes, NJ 07417 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-06 |
| Decision Date | 2013-02-07 |
| Summary: | summary |