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FDA 510(k) Application Details - K160450
Device Classification Name
Apparatus, Suction, Patient Care
More FDA Info for this Device
510(K) Number
K160450
Device Name
Apparatus, Suction, Patient Care
Applicant
CAREFUSION
75 NORTH FAIRWAY DRIVE
VERNON HILLS, IL 60061 US
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Contact
JOY GREIDANUS
Other 510(k) Applications for this Contact
Regulation Number
870.5050
More FDA Info for this Regulation Number
Classification Product Code
DWM
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More FDA Info for this Product Code
Date Received
02/18/2016
Decision Date
10/31/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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