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FDA 510(k) Application Details - K020700
Device Classification Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K020700
Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant
PEGASUS RESEARCH CORP.
1714 SOUTH LYON ST.
SANTA ANA, CA 92705 US
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Contact
KENNETH G MILLER
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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
03/04/2002
Decision Date
04/26/2004
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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