The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Ney-oro 41.
Device ID | K870677 |
510k Number | K870677 |
Device Name: | NEY-ORO 41 |
Classification | Alloy, Gold-based Noble Metal |
Applicant | DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield, CT 06002 |
Contact | Donald V Landmann |
Correspondent | Donald V Landmann 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 | 1987-02-19 |
Decision Date | 1987-05-12 |