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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
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