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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 K111263
Device Name CXI TRIFORCE
Applicant
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Applicant Contact MOLLY BUSENBARK
Correspondent
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Correspondent Contact MOLLY BUSENBARK
Regulation Number870.1210
Classification Product Code
KRA  
Date Received05/04/2011
Decision Date 07/25/2011
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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