FDA 510(k) Application Details - K120334

Device Classification Name Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

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510(K) Number K120334
Device Name Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Applicant ETVIEW LTD.
31 HAAVODA ST.
BINYAMINA 30500 IL
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Contact YORAM LEVY
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Regulation Number 868.5740

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Classification Product Code CBI
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Date Received 02/03/2012
Decision Date 06/08/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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