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FDA 510(k) Application Details - K181886
Device Classification Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
More FDA Info for this Device
510(K) Number
K181886
Device Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Applicant
ETView Ltd.
M.P Misgav
Misgav Business Park 2017900 IL
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Contact
Yoram Levy
Other 510(k) Applications for this Contact
Regulation Number
868.5740
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Classification Product Code
CBI
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More FDA Info for this Product Code
Date Received
07/13/2018
Decision Date
11/14/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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