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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
Applicant
Nellie Medical, LLC
18 Hillside Drive
Holliston,  MA  01746
Applicant Contact Ronald Adams
Correspondent
R&Q Solutions
Boston,  MA  02108
Correspondent Contact Christine Santagate
Regulation Number876.5130
Classification Product Code
EZL  
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
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