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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K142934
Device Name CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved
Applicant
Covidien
161 Cheshire Lane, Suite 100
Plymouth,  MN  55441
Applicant Contact Deborah Fleetham
Correspondent
Covidien
161 Cheshire Lane, Suite 100
Plymouth,  MN  55441
Correspondent Contact Deborah Fleetham
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received10/09/2014
Decision Date 06/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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