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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 K122531
Device Name SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T
Applicant
Covidien
6135 Gunbarrel Ave.
Boulder,  CO  80021
Applicant Contact TED KUHN
Correspondent
Covidien
6135 Gunbarrel Ave.
Boulder,  CO  80021
Correspondent Contact TED KUHN
Regulation Number868.5800
Classification Product Code
JOH  
Date Received08/20/2012
Decision Date 10/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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