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FDA 510(k) Application Details - K162242
Device Classification Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K162242
Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant
TELEFLEX MEDICAL, INC
2917 WECK DRIVE
RESEARCH TRIANGLE PARK, NC 27709 US
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Contact
BRIAN GALL
Other 510(k) Applications for this Contact
Regulation Number
868.5450
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Classification Product Code
BTT
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More FDA Info for this Product Code
Date Received
08/10/2016
Decision Date
01/19/2017
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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