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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K112314
Device Name NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER
Applicant
NEPHROS, INC.
41 GRAND AVE.
RIVER EDGE,  NJ  07661
Applicant Contact GREG COLLINS
Correspondent
NEPHROS, INC.
41 GRAND AVE.
RIVER EDGE,  NJ  07661
Correspondent Contact GREG COLLINS
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/11/2011
Decision Date 04/27/2012
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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