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FDA 510(k) Application Details - K993355
Device Classification Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K993355
Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant
HUDSON RESPIRATORY CARE, INC.
27711 DIAZ RD.
P.O. BOX 9020
TEMECULA, CA 92589-9020 US
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Contact
CHARLES MIERKIEWICZ
Other 510(k) Applications for this Contact
Regulation Number
868.5450
More FDA Info for this Regulation Number
Classification Product Code
BTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/06/1999
Decision Date
05/24/2000
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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