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FDA 510(k) Application Details - K151381
Device Classification Name
Tube, Tracheal (W/Wo Connector)
More FDA Info for this Device
510(K) Number
K151381
Device Name
Tube, Tracheal (W/Wo Connector)
Applicant
Covidien
6135 Gunbarrel Ave
Boulder, CO 80301 US
Other 510(k) Applications for this Company
Contact
Danielle Mueller
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
05/22/2015
Decision Date
12/11/2015
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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