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FDA 510(k) Application Details - K141747
Device Classification Name
Tube, Tracheal (W/Wo Connector)
More FDA Info for this Device
510(K) Number
K141747
Device Name
Tube, Tracheal (W/Wo Connector)
Applicant
DAVIS MEDICAL
12602 N. SUMMER WIND DRIVE
MARANA, AZ 85658 US
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Contact
MICHELLE LOTT
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
06/30/2014
Decision Date
04/20/2015
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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