The following data is part of a premarket notification filed by Coeur, Inc. with the FDA for Mr Syringe Dual Pack For Solaris Injectors.
| Device ID | K161471 |
| 510k Number | K161471 |
| Device Name: | MR Syringe Dual Pack For Solaris Injectors |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Coeur, Inc. 100 Physicians Way Lebanon, TN 37090 |
| Contact | Priscilla Clinner |
| Correspondent | Priscilla Clinner Coeur, Inc. 100 Physicians Way 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 | 2016-05-27 |
| Decision Date | 2016-10-06 |
| Summary: | summary |