The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Gdc 934.
Device ID | K801277 |
510k Number | K801277 |
Device Name: | GDC 934 |
Classification | Alloy, Other Noble Metal |
Applicant | DERINGER-NEY INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EJS |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-05-29 |
Decision Date | 1980-07-21 |