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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 K022448
Device Name WATER PURIFICATION SYSTEM
Applicant
PURITY WATER COMPANY OF SAN ANTONIO, INC.
803 EVIAN
SAN ANTONIO,  TX  78258
Applicant Contact BERT HUDSON
Correspondent
PURITY WATER COMPANY OF SAN ANTONIO, INC.
803 EVIAN
SAN ANTONIO,  TX  78258
Correspondent Contact BERT HUDSON
Regulation Number876.5665
Classification Product Code
FIP  
Date Received07/26/2002
Decision Date 05/28/2003
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
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