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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 K181722
Device Name Polyethylene Catheter
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 Number870.1200
Classification Product Code
DQO  
Date Received06/29/2018
Decision Date 03/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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