Cleared Traditional

K954749 - MALLINCKRODT SHILEY 15MM CAP
(FDA 510(k) Clearance)

K954749 · Mallinckrodt Medical · Anesthesiology
Jan 1996
Decision
100d
Days
Class 2
Risk

K954749 is an FDA 510(k) clearance for the MALLINCKRODT SHILEY 15MM CAP, 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 24, 1996, 100 days after receiving the submission on October 16, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K954749 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 1995
Decision Date January 24, 1996
Days to Decision 100 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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