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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K153430
Device Name Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
Applicant
Cook Incorporated
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact SARAH REEVES
Correspondent
Cook Incorporated
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact SARAH REEVES
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/25/2015
Decision Date 03/07/2016
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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