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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 K992786
Device Name PURE WATER, INC.'S WATER PURIFICATION SYSTEMS
Applicant
Pure Water, Inc.
305 W. Market St.
Anderson,  SC  29624
Applicant Contact CYNTHIA P WALTERS
Correspondent
Pure Water, Inc.
305 W. Market St.
Anderson,  SC  29624
Correspondent Contact CYNTHIA P WALTERS
Regulation Number876.5665
Classification Product Code
FIP  
Date Received08/19/1999
Decision Date 01/24/2000
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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