Cleared Special

KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305

K033189 · King Systems Corp. · Anesthesiology
May 2004
Decision
216d
Days
Class 1
Risk

About This 510(k) Submission

K033189 is an FDA 510(k) clearance for the KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305, 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 May 4, 2004, 216 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 K033189 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2003
Decision Date May 04, 2004
Days to Decision 216 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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