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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 K071104
Device Name ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
Applicant
FLIER'S QUALITY WATER SYSTEMS INC
7425 CLYDE PARK AVENUE SW
SUITE A
BYRON CENTER,  MI  49315
Applicant Contact JAMES FLIER
Correspondent
FLIER'S QUALITY WATER SYSTEMS INC
7425 CLYDE PARK AVENUE SW
SUITE A
BYRON CENTER,  MI  49315
Correspondent Contact JAMES FLIER
Regulation Number876.5665
Classification Product Code
FIP  
Date Received04/19/2007
Decision Date 01/14/2008
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
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