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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 K032426
Device Name GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
Applicant
Cook, Inc.
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402 -0489
Applicant Contact JENNIFER J BOSLEY
Correspondent
Cook, Inc.
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402 -0489
Correspondent Contact JENNIFER J BOSLEY
Regulation Number870.3375
Classification Product Code
DTK  
Date Received08/06/2003
Decision Date 10/31/2003
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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