The following data is part of a premarket notification filed by Am Usa with the FDA for Am Usa 0.9% Sodium Chloride Flush Syringe.
| Device ID | K113555 |
| 510k Number | K113555 |
| Device Name: | AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE |
| Classification | Saline, Vascular Access Flush |
| Applicant | AM USA 5209 LINDBAR DRIVE SUITE 630 Nashville, TN 37167 |
| Contact | Karen Thomison |
| Correspondent | Karen Thomison AM USA 5209 LINDBAR DRIVE SUITE 630 Nashville, TN 37167 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-01 |
| Decision Date | 2012-01-30 |
| Summary: | summary |