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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube tracheostomy and tube cuff
510(k) Number K051416
Device Name SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
Applicant
MALLINCKRODT MEDICAL
4280 HACIENDA DRIVE
PLEASANTON,  CA  94588
Applicant Contact PATRICK GARVEY
Correspondent
MALLINCKRODT MEDICAL
4280 HACIENDA DRIVE
PLEASANTON,  CA  94588
Correspondent Contact PATRICK GARVEY
Regulation Number868.5800
Classification Product Code
JOH  
Date Received06/01/2005
Decision Date 06/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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