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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stent, ureteral
510(k) Number K180029
Device Name Malecot Nephrostomy Catheter/Stent Set
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact Minjin Choi
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact Minjin Choi
Regulation Number876.4620
Classification Product Code
FAD  
Subsequent Product Code
LJE  
Date Received01/03/2018
Decision Date 09/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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