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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 K200670
Device Name EON Portable RO Water Purification System
Applicant
Mar Cor Purification, Inc.
14550 28th Avenue North
Minneapolis,  MN  55447
Applicant Contact Mark Arnold
Correspondent
Mar Cor Purification, Inc.
14550 28th Avenue North
Minneapolis,  MN  55447
Correspondent Contact Mark Arnold
Regulation Number876.5665
Classification Product Code
FIP  
Date Received03/13/2020
Decision Date 04/16/2020
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
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