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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 K043509
Device Name GUNTHER TULIP VENA CAVA FILTER SET
Original Applicant
COOK, INC.
750 daniels way
p.o. box 489
bloomington,  IN  47402
Original Contact earl e knight iii
Regulation Number870.3375
Classification Product Code
DTK  
Date Received12/21/2004
Decision Date 05/05/2005
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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