Cleared Traditional

SHILEY SPECIALIZED TRACHEOSTOMY TUBE

K903435 · Shiley, Inc. · Anesthesiology
Oct 1990
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K903435 is an FDA 510(k) clearance for the SHILEY SPECIALIZED TRACHEOSTOMY TUBE, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on October 2, 1990, 63 days after receiving the submission on July 31, 1990. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K903435 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1990
Decision Date October 02, 1990
Days to Decision 63 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code JOH — Tube Tracheostomy And Tube Cuff
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

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