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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K072724
Device Name CXI SUPPORT CATHETER
Applicant
Cook, Inc.
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact KAREN BRADBURN
Correspondent
Cook, Inc.
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact KAREN BRADBURN
Regulation Number870.1210
Classification Product Code
KRA  
Date Received09/26/2007
Decision Date 11/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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