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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name subsystem, water purification
510(k) Number K161304
Device Name EndoPur Filter
Nephros Inc.
41 Grand Ave
River Edge,  NJ  07661
Applicant Contact Hollie Johnson
Nephros Inc.
41 Grand Ave
River Edge,  NJ  07661
Correspondent Contact Hollie Johnson
Regulation Number876.5665
Classification Product Code
Date Received05/10/2016
Decision Date 03/02/2017
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