510(k) K071694

COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX by Daiken Medical Co, Ltd. — Product Code CBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2008
Date Received
June 20, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5740
Review Panel
AN
Submission Type