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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 K073374
Device Name COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
Applicant
WILLIAM COOK EUROPE APS
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON,  IN  47402 -0489
Applicant Contact MOLLY BUSENBARK
Correspondent
WILLIAM COOK EUROPE APS
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON,  IN  47402 -0489
Correspondent Contact MOLLY BUSENBARK
Regulation Number870.3375
Classification Product Code
DTK  
Date Received12/03/2007
Decision Date 03/07/2008
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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