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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 K250514
Device Name UPT Series Medical RO Water Treatment System
Applicant
Specialty Water Technologies, Inc
104 Flex Ave
Portland,  TN  37148
Applicant Contact Alex Clark
Correspondent
DuVal & Associates
Suite 1820, Medical Arts Building, 825 Nicollet Mall
Minneapolis,  MN  55402
Correspondent Contact Mark Spreeman
Regulation Number876.5665
Classification Product Code
FIP  
Date Received02/21/2025
Decision Date 03/17/2025
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
Predetermined Change
Control Plan Authorized		 No
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