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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 K071694
Device Name COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX
Applicant
Daiken Medical Co, Ltd.
4-2-1 Yushima
Bunkyo-Ku
Tokyo,  JP 113-0034
Applicant Contact FUMIAK KANAI
Correspondent
Daiken Medical Co, Ltd.
4-2-1 Yushima
Bunkyo-Ku
Tokyo,  JP 113-0034
Correspondent Contact FUMIAK KANAI
Regulation Number868.5740
Classification Product Code
CBI  
Date Received06/20/2007
Decision Date 03/20/2008
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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