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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 K181735
Device Name Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact Paul Meyer
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact Paul Meyer
Classification Product Code
LJE  
Date Received07/02/2018
Decision Date 03/27/2019
Decision Substantially Equivalent - Kit (SESK)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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