Cleared Traditional

NEY EQUI-HINGE

K790290 · Deringer-Ney, Inc. · Dental
Apr 1979
Decision
61d
Days
Class 1
Risk

About This 510(k) Submission

K790290 is an FDA 510(k) clearance for the NEY EQUI-HINGE, a Sterilizer, Boiling Water (Class I — General Controls, product code ECG), submitted by Deringer-Ney, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1979, 61 days after receiving the submission on February 8, 1979. This device falls under the Dental review panel. Regulated under 21 CFR 872.6710.

Submission Details

510(k) Number K790290 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 1979
Decision Date April 10, 1979
Days to Decision 61 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code ECG — Sterilizer, Boiling Water
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6710