The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Ultra High Pressure Injector Lines.
| Device ID | K023591 |
| 510k Number | K023591 |
| Device Name: | ULTRA HIGH PRESSURE INJECTOR LINES |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Gracie Greenway |
| Correspondent | Gracie Greenway DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-25 |
| Decision Date | 2003-06-18 |
| Summary: | summary |