The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Angiography Kits.
| Device ID | K152978 |
| 510k Number | K152978 |
| Device Name: | DeRoyal Angiography Kits |
| Classification | Injector And Syringe, Angiographic |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LANE Powell, TN 37849 |
| Contact | Elizabeth Wheeler |
| Correspondent | Elizabeth Wheeler DEROYAL INDUSTRIES, INC. 200 DEBUSK LANE Powell, TN 37849 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-09 |
| Decision Date | 2016-03-25 |
| Summary: | summary |