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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 K153084
Device Name Nephros S100
Applicant
Nephros, Inc.
41 Grand Ave.
River Edge,  NJ  07661
Applicant Contact JAMES SUMMERTON
Correspondent
Nephros, Inc.
41 Grand Ave.
River Edge,  NJ  07661
Correspondent Contact JAMES SUMMERTON
Regulation Number876.5665
Classification Product Code
NHV  
Date Received10/26/2015
Decision Date 04/08/2016
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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