Cleared Traditional

TRACHEOSTOMY CARE TRAY

K921733 · Medikmark, Inc. · Anesthesiology
Jun 1994
Decision
796d
Days
Class 2
Risk

About This 510(k) Submission

K921733 is an FDA 510(k) clearance for the TRACHEOSTOMY CARE TRAY, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Medikmark, Inc. (Chicago, US). The FDA issued a Cleared decision on June 15, 1994, 796 days after receiving the submission on April 10, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K921733 FDA.gov
FDA Decision Cleared SESK
Date Received April 10, 1992
Decision Date June 15, 1994
Days to Decision 796 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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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