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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
510(k) Number K093888
Device Name COOPDECH ENDOBRONCHIAL BLOCKER TUBE
Applicant
Daiken Medical Co, Ltd.
4-1-17 Hongo, Bunkyo-Ku
Tokyo,  JP 113-0033
Applicant Contact FUMIAKI KANAI
Correspondent
Daiken Medical Co, Ltd.
4-1-17 Hongo, Bunkyo-Ku
Tokyo,  JP 113-0033
Correspondent Contact FUMIAKI KANAI
Regulation Number868.5740
Classification Product Code
CBI  
Date Received12/18/2009
Decision Date 03/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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