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FDA 510(k) Application Details - K083119
Device Classification Name
Tube, Tracheal (W/Wo Connector)
More FDA Info for this Device
510(K) Number
K083119
Device Name
Tube, Tracheal (W/Wo Connector)
Applicant
SMITHS MEDICAL ASD, INC.
BOUNDARY ROAD
HYTHE, KENT CT216JN GB
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Contact
JOHN TULLETT
Other 510(k) Applications for this Contact
Regulation Number
868.5730
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Classification Product Code
BTR
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More FDA Info for this Product Code
Date Received
10/22/2008
Decision Date
06/26/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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