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FDA 510(k) Application Details - K061736
Device Classification Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
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510(K) Number
K061736
Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant
TELEFLEX MEDICAL
2345 WAUKEGAN ROAD
BANNOCKBURN, IL 60015 US
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Contact
LORI HAYS
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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
06/20/2006
Decision Date
08/18/2006
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
Y
Expedited Review
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