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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, retention type, balloon
510(k) Number K172422
Device Name Kohli Urinary Drainage Catheter
Nellie Medical, LLC
18 Hillside Drive
Holliston,  MA  01746
Applicant Contact Ronald Adams
R&Q Solutions
Boston,  MA  02108
Correspondent Contact Christine Santagate
Regulation Number876.5130
Classification Product Code
Date Received08/10/2017
Decision Date 02/09/2018
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