The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Gdc-1629 A Casting Alloy.
| Device ID | K850101 |
| 510k Number | K850101 |
| Device Name: | GDC-1629 A CASTING ALLOY |
| Classification | Alloy, Other Noble Metal |
| Applicant | DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield, CT 06002 |
| Contact | Donald V Landman |
| Correspondent | Donald V Landman DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield, CT 06002 |
| Product Code | EJS |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-11 |
| Decision Date | 1985-02-08 |