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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 K061815
Device Name COOK CELECT VENA CAVA FILTER
Applicant
William Cook Europe Aps
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402 -0489
Applicant Contact THALIA BRINE
Correspondent
William Cook Europe Aps
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402 -0489
Correspondent Contact THALIA BRINE
Regulation Number870.3375
Classification Product Code
DTK  
Date Received06/27/2006
Decision Date 04/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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