The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Gdc 1453 Casting Alloy.
Device ID | K854285 |
510k Number | K854285 |
Device Name: | GDC 1453 CASTING ALLOY |
Classification | Alloy, Metal, Base |
Applicant | DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield, CT 06002 |
Contact | Donald Landmann |
Correspondent | Donald Landmann DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield, CT 06002 |
Product Code | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-10-25 |
Decision Date | 1985-12-27 |