The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Gdc-1501.
| Device ID | K904695 |
| 510k Number | K904695 |
| Device Name: | GDC-1501 |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield, CT 06002 |
| Contact | John M Kuzmech |
| Correspondent | John M Kuzmech DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield, CT 06002 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-16 |
| Decision Date | 1991-01-02 |