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FDA 510(k) Application Details - K062091
Device Classification Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
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510(K) Number
K062091
Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant
POROUS MEDIA CORP.
1350 HAMMOND RD.
ST. PAUL, MN 55110 US
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Contact
KEITH A ROBERTS
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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
07/24/2006
Decision Date
08/08/2006
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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