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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 K182071
Device Name Multi-Sideport Catheter Infusion Set
Applicant
Cook Incorporated
P.O. Box 489, 750 Daniels Way
Bloomington,  IN  47402
Applicant Contact Reuben Lidster
Correspondent
Cook Incorporated
P.O. Box 489, 750 Daniels Way
Bloomington,  IN  47402
Correspondent Contact Reuben Lidster
Regulation Number870.1210
Classification Product Code
KRA  
Date Received08/01/2018
Decision Date 04/25/2019
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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