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510(k) K160542

5.0 Fr Arndt Endobronchial Blocker Set by Cook Incorporated — Product Code CBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2016
Date Received
February 26, 2016
Clearance Type
Special
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

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