NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER


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

Correspodent Contact greg collins
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 08/11/2011
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