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FDA 510(k) Application Details - K142296
Device Classification Name
Tube Tracheostomy And Tube Cuff
More FDA Info for this Device
510(K) Number
K142296
Device Name
Tube Tracheostomy And Tube Cuff
Applicant
Covidien
6135 Gunbarrel Ave
Boulder, CO 80301 US
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Contact
Danielle Mueller
Other 510(k) Applications for this Contact
Regulation Number
868.5800
More FDA Info for this Regulation Number
Classification Product Code
JOH
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More FDA Info for this Product Code
Date Received
08/18/2014
Decision Date
02/24/2015
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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