Cleared Traditional

JED-LIGHT FIBEROPTIC LIGHT SOURCE

K954184 · Jedmed Instrument Co. · Ear, Nose, Throat
Nov 1995
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K954184 is an FDA 510(k) clearance for the JED-LIGHT FIBEROPTIC LIGHT SOURCE, a Source, Carrier, Fiberoptic Light (Class I — General Controls, product code EQH), submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on November 13, 1995, 68 days after receiving the submission on September 6, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4350.

Submission Details

510(k) Number K954184 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 1995
Decision Date November 13, 1995
Days to Decision 68 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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