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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 K121629
Device Name COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR
Applicant
WILLIAM COOK EUROPE APS
1 Geddes Way
West Lafayette,  IN  47906
Applicant Contact Jennifer Brown
Correspondent
WILLIAM COOK EUROPE APS
1 Geddes Way
West Lafayette,  IN  47906
Correspondent Contact Jennifer Brown
Regulation Number870.3375
Classification Product Code
DTK  
Date Received06/04/2012
Decision Date 07/03/2012
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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