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 Sf Syringe.
| Device ID | K153481 |
| 510k Number | K153481 |
| Device Name: | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe |
| Classification | Saline, Vascular Access Flush |
| Applicant | BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes, NJ 07417 |
| Contact | John Blewitt |
| Correspondent | John Blewitt BECTON, DICKINSON AND COMPANY 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 | 2015-12-03 |
| Decision Date | 2016-04-04 |
| Summary: | summary |