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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name filter, intravascular, cardiovascular
510(k) Number K073528
Device Name VENA CAVA FILTER
Original Applicant
COOK INCORPORATED
750 daniels way
bloomington,  IN  47404
Original Contact molly busenbank
Regulation Number870.3375
Classification Product Code
DTK  
Date Received12/17/2007
Decision Date 02/27/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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