Cleared Special

KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205

K033186 · King Systems Corp. · Anesthesiology
Apr 2004
Decision
196d
Days
Class 1
Risk

About This 510(k) Submission

K033186 is an FDA 510(k) clearance for the KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205, a Airway, Oropharyngeal, Anesthesiology (Class I — General Controls, product code CAE), submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on April 14, 2004, 196 days after receiving the submission on October 1, 2003. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5110.

Submission Details

510(k) Number K033186 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2003
Decision Date April 14, 2004
Days to Decision 196 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAE — Airway, Oropharyngeal, Anesthesiology
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5110

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