The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Gdc-1489 A Casting Alloy.
Device ID | K850103 |
510k Number | K850103 |
Device Name: | GDC-1489 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 |