Cleared Traditional

SYSTEMA ENT CABINET

K896273 · Jedmed Instrument Co. · Ear, Nose, Throat
Jan 1990
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K896273 is an FDA 510(k) clearance for the SYSTEMA ENT CABINET, a Unit, Examining/treatment, Ent (Class I — General Controls, product code ETF), submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on January 26, 1990, 88 days after receiving the submission on October 30, 1989. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5300.

Submission Details

510(k) Number K896273 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 1989
Decision Date January 26, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code ETF — Unit, Examining/treatment, Ent
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.5300

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