Cleared Traditional

TRACHEOSTOMY CARE KIT

K924243 · Transidyne General Corp. · Anesthesiology
Jun 1993
Decision
296d
Days
Class 2
Risk

About This 510(k) Submission

K924243 is an FDA 510(k) clearance for the TRACHEOSTOMY CARE KIT, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Transidyne General Corp. (Spartanburg, US). The FDA issued a Cleared decision on June 16, 1993, 296 days after receiving the submission on August 24, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K924243 FDA.gov
FDA Decision Cleared SEKD
Date Received August 24, 1992
Decision Date June 16, 1993
Days to Decision 296 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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