NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER


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

Correspodent Contact james summerton
Regulation Number 876.5665
Classification Product Code
FIP  
Date Received 01/31/2011
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