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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 K994292
Device Name WATER PURIFICATION SYSTEM
Applicant
Water & Power Technologies, Inc.
3535 Firewheel Dr.
Suite A
Flower Mound,  TX  75028 -2628
Applicant Contact BARRY PEARCE
Correspondent
Water & Power Technologies, Inc.
3535 Firewheel Dr.
Suite A
Flower Mound,  TX  75028 -2628
Correspondent Contact BARRY PEARCE
Regulation Number876.5665
Classification Product Code
FIP  
Date Received12/21/1999
Decision Date 01/02/2001
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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