Cleared Traditional

MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE

K945513 · Mallinckrodt Medical · Anesthesiology
Jan 1995
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K945513 is an FDA 510(k) clearance for the MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE, 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 January 13, 1995, 65 days after receiving the submission on November 9, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K945513 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1994
Decision Date January 13, 1995
Days to Decision 65 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

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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