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FDA 510(k) Application Details - K052615
Device Classification Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K052615
Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant
MEDISIZE BV
EDISONSTRAAT 1
HILLEGOM 2180 AB NL
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Contact
SOPIHA LAM
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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
09/23/2005
Decision Date
12/09/2005
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
Y
Expedited Review
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