The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for 0.9% Sodium Chloride Injection, Usp Bd Posiflush; Sp Syringe, Sf Syringe.
| Device ID | K141311 |
| 510k Number | K141311 |
| Device Name: | 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE |
| Classification | Saline, Vascular Access Flush |
| Applicant | Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Contact | Juma Hoshino |
| Correspondent | Juma Hoshino Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-20 |
| Decision Date | 2014-07-25 |
| Summary: | summary |