Cleared Traditional

GUEDEL AIRWAY

K953400 · Mallinckrodt Medical · Anesthesiology
Oct 1995
Decision
96d
Days
Class 1
Risk

About This 510(k) Submission

K953400 is an FDA 510(k) clearance for the GUEDEL AIRWAY, a Airway, Oropharyngeal, Anesthesiology (Class I — General Controls, product code CAE), submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on October 24, 1995, 96 days after receiving the submission on July 20, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5110.

Submission Details

510(k) Number K953400 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1995
Decision Date October 24, 1995
Days to Decision 96 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

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

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