The following data is part of a premarket notification filed by Medroyal, Inc. with the FDA for Medroyal Angiographic Control Syringe.
| Device ID | K920135 |
| 510k Number | K920135 |
| Device Name: | MEDROYAL ANGIOGRAPHIC CONTROL SYRINGE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDROYAL, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning MEDROYAL, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-13 |
| Decision Date | 1992-07-24 |