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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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