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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 K090885
Device Name NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER
Applicant
NEPHROS, INC.
41 GRAND AVE.
SUITE 201
RIVER EDGE,  NJ  07661
Applicant Contact VIKKI M O'CONNOR
Correspondent
NEPHROS, INC.
41 GRAND AVE.
SUITE 201
RIVER EDGE,  NJ  07661
Correspondent Contact VIKKI M O'CONNOR
Regulation Number876.5665
Classification Product Code
FIP  
Date Received03/31/2009
Decision Date 06/29/2009
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
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