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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 K142839
Device Name GenCut Core Biopsy System
Applicant
Covidien LLC
161 Cheshire Lane, Suite 100
Plymouth,  MN  55441
Applicant Contact Jenny Jiang
Correspondent
Covidien LLC
161 Cheshire Lane, Suite 100
Plymouth,  MN  55441
Correspondent Contact Jenny Jiang
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received09/30/2014
Decision Date 04/29/2015
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
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