The following data is part of a premarket notification filed by Coeur, Inc. with the FDA for Mr Syringe Dual Pack.
| Device ID | K140469 |
| 510k Number | K140469 |
| Device Name: | MR SYRINGE DUAL PACK |
| Classification | Injector And Syringe, Angiographic |
| Applicant | COEUR, INC. 100 PHYSICIANS WAY SUITE 200 Lebanon, TN 37090 |
| Contact | Erin Rheinscheld |
| Correspondent | Erin Rheinscheld COEUR, INC. 100 PHYSICIANS WAY SUITE 200 Lebanon, TN 37090 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-25 |
| Decision Date | 2014-07-28 |
| Summary: | summary |