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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 K192398
Device Name Millenium HX
Mar Cor Purification, Inc.
14550 28th Avenue North
Minneapolis,  MN  55447
Applicant Contact Mike Halliday
9800 59th Ave. N
Plymouth,  MN  55442
Correspondent Contact Mark Arnold
Regulation Number876.5665
Classification Product Code
Date Received09/03/2019
Decision Date 10/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No