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.
| Device ID | K161552 |
| 510k Number | K161552 |
| Device Name: | 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe |
| Classification | Saline, Vascular Access Flush |
| Applicant | Becton Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07045 |
| Contact | John Blewitt |
| Correspondent | John Blewitt Becton Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07045 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-06 |
| Decision Date | 2017-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903064934 | K161552 | 000 |
| 50382903064958 | K161552 | 000 |
| 50382903064996 | K161552 | 000 |