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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 K011005
Device Name PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS
Applicant
PURE WATER SOLUTIONS, INC.
3925 WEST NORTHSIDE DR.
JACKSON,  MS  39209
Applicant Contact JOHN BOWER
Correspondent
PURE WATER SOLUTIONS, INC.
3925 WEST NORTHSIDE DR.
JACKSON,  MS  39209
Correspondent Contact JOHN BOWER
Regulation Number876.5665
Classification Product Code
FIP  
Date Received04/04/2001
Decision Date 11/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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