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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 K161467
Device Name HydraGuard 10 UltraFilter
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 Hollie Johnson
Regulation Number876.5665
Classification Product Code
NHV  
Date Received05/27/2016
Decision Date 12/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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