The following data is part of a premarket notification filed by Osprey Medical, Inc. with the FDA for Contrast Conservation System.
| Device ID | K131478 |
| 510k Number | K131478 |
| Device Name: | CONTRAST CONSERVATION SYSTEM |
| Classification | Injector And Syringe, Angiographic |
| Applicant | OSPREY MEDICAL, INC. 7600 EXECUTIVE DR Eden Prairie, MN 55344 |
| Contact | Jill Munsinger |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-05-22 |
| Decision Date | 2013-08-15 |
| Summary: | summary |