The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Neyoro 65cf.
Device ID | K890569 |
510k Number | K890569 |
Device Name: | NEYORO 65CF |
Classification | Alloy, Gold-based Noble Metal |
Applicant | DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield, CT 06002 |
Contact | John M Kuzmech |
Correspondent | John M Kuzmech DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield, CT 06002 |
Product Code | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-06 |
Decision Date | 1989-03-09 |