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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Water Purification, General Medical Use
510(k) Number K182164
Device Name Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand
Applicant
Ecolab, Inc.
1 Ecolab Pl.
St. Paul,  MN  55102
Applicant Contact Jennifer Willner
Correspondent
Ecolab, Inc.
1 Ecolab Pl.
St. Paul,  MN  55102
Correspondent Contact Charles Pouliot
Regulation Number876.5665
Classification Product Code
NHV  
Date Received08/10/2018
Decision Date 03/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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