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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 K142298
Device Name Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff
6135 Gunbarrel Avenue
Boulder,  CO  80301
Applicant Contact Kelsey Lee
6135 Gunbarrel Avenue
Boulder,  CO  80301
Correspondent Contact Danielle Mueller
Regulation Number868.5800
Classification Product Code
Date Received08/18/2014
Decision Date 02/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls