The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Gdc 1448 Development Name.
Device ID | K833596 |
510k Number | K833596 |
Device Name: | GDC 1448 DEVELOPMENT NAME |
Classification | Alloy, Other Noble Metal |
Applicant | DERINGER-NEY INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EJS |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-12 |
Decision Date | 1983-12-29 |