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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
Original Applicant
COVIDIEN
6135 gunbarrel ave.
boulder,  CO  80021
Original 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
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