MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM


Device Classification Name

subsystem, water purification

510(k) Number K110578
Device Name MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM
Applicant
MAR COR PURIFICATION, INC.
14605 28th avenue north
minneapolis, 
MN 
55447

Applicant Contact brent geiger
Correspondent
MAR COR PURIFICATION, INC.
14605 28th avenue north
minneapolis, 
MN 
55447

Correspodent Contact brent geiger
Regulation Number 876.5665
Classification Product Code
FIP  
Date Received 03/01/2011
Decision Date 05/20/2011
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

Recalls CDRH Recalls