The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Ney Equi-hinge.
Device ID | K790290 |
510k Number | K790290 |
Device Name: | NEY EQUI-HINGE |
Classification | Sterilizer, Boiling Water |
Applicant | DERINGER-NEY INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ECG |
CFR Regulation Number | 872.6710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-02-08 |
Decision Date | 1979-04-10 |