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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 K003315
Device Name SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
Applicant
MALLINCKRODT, INC.
3 MISSOURI RESEARCH PARK DR.
ST. CHARLES,  MO  63304
Applicant Contact JAMES C KEEVEN
Correspondent
MALLINCKRODT, INC.
3 MISSOURI RESEARCH PARK DR.
ST. CHARLES,  MO  63304
Correspondent Contact JAMES C KEEVEN
Regulation Number868.5800
Classification Product Code
JOH  
Date Received10/23/2000
Decision Date 11/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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