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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K161822
Device Name Torcon NB Advantage Catheters
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47402
Applicant Contact Jennifer Allman
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47402
Correspondent Contact Jennifer Allman
Regulation Number870.1200
Classification Product Code
DQO  
Date Received07/01/2016
Decision Date 10/27/2016
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
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