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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 K173164
Device Name Ecolab POU Water Filter
Applicant
Ecolab, Inc.
One Ecolab Pl.
St. Paul,  MN  55102
Applicant Contact Jennifer Willner
Correspondent
Ecolab, Inc.
One Ecolab Pl.
St. Paul,  MN  55102
Correspondent Contact Jennifer Willner
Regulation Number876.5665
Classification Product Code
NHV  
Date Received09/29/2017
Decision Date 06/29/2018
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
Predetermined Change
Control Plan Authorized		 No
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