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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, nephrostomy
510(k) Number K183051
Device Name Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact Yan Li
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact Yan Li
Classification Product Code
LJE  
Date Received11/02/2018
Decision Date 07/16/2019
Decision Substantially Equivalent - Kit (SESK)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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