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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
Applicant
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON,  IN  47402
Applicant Contact EARL E KNIGHT III
Correspondent
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON,  IN  47402
Correspondent Contact EARL E KNIGHT III
Regulation Number870.3375
Classification Product Code
DTK  
Date Received12/20/2004
Decision Date 05/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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