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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 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
Correspondent Contact Brent Geiger
Regulation Number876.5665
Classification Product Code
FIP  
Date Received03/01/2011
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
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