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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 K022747
Device Name HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM
Applicant
Hydropure Systems, Inc.
3319 Bartlett Blvd.
Orlando,  FL  32817
Applicant Contact ROBERT V PRICE
Correspondent
Hydropure Systems, Inc.
3319 Bartlett Blvd.
Orlando,  FL  32817
Correspondent Contact ROBERT V PRICE
Regulation Number876.5665
Classification Product Code
FIP  
Date Received08/19/2002
Decision Date 02/11/2003
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
Predetermined Change
Control Plan Authorized		 No
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