Cleared Traditional

MEDNEXT BUR

K935584 · Mednext, Inc. · Ear, Nose, Throat
Feb 1994
Decision
96d
Days
Class 1
Risk

About This 510(k) Submission

K935584 is an FDA 510(k) clearance for the MEDNEXT BUR, a Bur, Ear, Nose And Throat (Class I — General Controls, product code EQJ), submitted by Mednext, Inc. (West Point Beach, US). The FDA issued a Cleared decision on February 22, 1994, 96 days after receiving the submission on November 18, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4140.

Submission Details

510(k) Number K935584 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1993
Decision Date February 22, 1994
Days to Decision 96 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code EQJ — Bur, Ear, Nose And Throat
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4140