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FDA 510(k) Application Details - K060945
Device Classification Name
Tube, Tracheostomy (W/Wo Connector)
More FDA Info for this Device
510(K) Number
K060945
Device Name
Tube, Tracheostomy (W/Wo Connector)
Applicant
SMITHS MEDICAL INTERNATIONAL
1 ST. CRISPIN WAY
HASLINGDEN
ROSSENDALE, LANCASHIRE BB4 4PW GB
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Contact
STEWART LEE
Other 510(k) Applications for this Contact
Regulation Number
868.5800
More FDA Info for this Regulation Number
Classification Product Code
BTO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/06/2006
Decision Date
06/19/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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