SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

Tube Tracheostomy And Tube Cuff

MALLINCKRODT, INC.

The following data is part of a premarket notification filed by Mallinckrodt, Inc. with the FDA for Shiley Tracheosoft Xlt Extended Length Tracheostomy Tube And Disposable Inner Cannula.

Pre-market Notification Details

Device IDK003315
510k NumberK003315
Device Name:SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
ClassificationTube Tracheostomy And Tube Cuff
Applicant MALLINCKRODT, INC. 3 MISSOURI RESEARCH PARK DR. St. Charles,  MO  63304
ContactJames C Keeven
CorrespondentJames C Keeven
MALLINCKRODT, INC. 3 MISSOURI RESEARCH PARK DR. St. Charles,  MO  63304
Product CodeJOH  
CFR Regulation Number868.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-23
Decision Date2000-11-08

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