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FDA 510(k) Application Details - K090352
Device Classification Name
Tube, Tracheal (W/Wo Connector)
More FDA Info for this Device
510(K) Number
K090352
Device Name
Tube, Tracheal (W/Wo Connector)
Applicant
COVIDIEN
6135 GUNBARREL AVE.
BOULDER, CO 80516 US
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Contact
TED KUHN
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
02/11/2009
Decision Date
04/03/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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