Cleared Traditional

K955680 - SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED
(FDA 510(k) Clearance)

K955680 · Mallinckrodt Medical · Anesthesiology
Mar 1996
Decision
90d
Days
Class 2
Risk

K955680 is an FDA 510(k) clearance for the SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED. This device is classified as a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH).

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on March 13, 1996, 90 days after receiving the submission on December 14, 1995.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K955680 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1995
Decision Date March 13, 1996
Days to Decision 90 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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