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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 K110285
Device Name NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER
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
FIP  
Date Received01/31/2011
Decision Date 07/14/2011
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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