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FDA 510(k) Application Details - K121028
Device Classification Name
Tube, Tracheal (W/Wo Connector)
More FDA Info for this Device
510(K) Number
K121028
Device Name
Tube, Tracheal (W/Wo Connector)
Applicant
ETVIEW LTD.
31 HAAVODA ST.
BINYAMINA 30500 IL
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Contact
YORAM LEVY
Other 510(k) Applications for this Contact
Regulation Number
868.5730
More FDA Info for this Regulation Number
Classification Product Code
BTR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/05/2012
Decision Date
06/21/2012
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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