510(k) K121462

EZ-BLOCKER by Ez-Blocker B.V. — Product Code CBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2012
Date Received
May 17, 2012
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