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FDA 510(k) Application Details - K171917
Device Classification Name
Tube, Tracheal (W/Wo Connector)
More FDA Info for this Device
510(K) Number
K171917
Device Name
Tube, Tracheal (W/Wo Connector)
Applicant
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington, IN 47404 US
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Contact
Kotei Aoki
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
06/27/2017
Decision Date
04/23/2018
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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