The following data is part of a premarket notification filed by Amusa with the FDA for 0.9% Sodium Chloride Flush Syringe.
| Device ID | K133685 |
| 510k Number | K133685 |
| Device Name: | 0.9% SODIUM CHLORIDE FLUSH SYRINGE |
| Classification | Saline, Vascular Access Flush |
| Applicant | AMUSA 5209 Linbar Dr Ste 640 Nashville, TN 37211 |
| Contact | Alex Ferri |
| Correspondent | Alex Ferri AMUSA 5209 Linbar Dr Ste 640 Nashville, TN 37211 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-02 |
| Decision Date | 2014-08-13 |
| Summary: | summary |