Cleared Traditional

MID LABS TWIN ILLUMINATOR

K932131 · Medical Instrument Development Laboratories, Inc. · Ear, Nose, Throat
Apr 1994
Decision
333d
Days
Class 1
Risk

About This 510(k) Submission

K932131 is an FDA 510(k) clearance for the MID LABS TWIN ILLUMINATOR, a Source, Carrier, Fiberoptic Light (Class I — General Controls, product code EQH), submitted by Medical Instrument Development Laboratories, Inc. (San Leandro, US). The FDA issued a Cleared decision on April 1, 1994, 333 days after receiving the submission on May 3, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4350.

Submission Details

510(k) Number K932131 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1993
Decision Date April 01, 1994
Days to Decision 333 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code EQH — Source, Carrier, Fiberoptic Light
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4350

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