FDA 510(k) Application Details - K141965

Device Classification Name Apparatus, Suction, Patient Care

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510(K) Number K141965
Device Name Apparatus, Suction, Patient Care
Applicant CAREFUSION
75 NORTH FAIRWAY DRIVE
VERNON HILLS, IL 60061 US
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Contact JOY GREIDANUS
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Regulation Number 870.5050

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Classification Product Code DWM
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Date Received 07/21/2014
Decision Date 07/02/2015
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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