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FDA 510(k) Application Details - K990614
Device Classification Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K990614
Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant
KING SYSTEMS CORP.
15011 HERRIMAN BLVD.
P.O. BOX 1138
NOBLESVILLE, IN 46060 US
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Contact
CHARLES A BURT
Other 510(k) Applications for this Contact
Regulation Number
868.5450
More FDA Info for this Regulation Number
Classification Product Code
BTT
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More FDA Info for this Product Code
Date Received
02/25/1999
Decision Date
05/23/2000
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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