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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 K994279
Device Name PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
Applicant
PURE WATER SOLUTIONS, INC.
14550 EAST EASTER AVE., #800
ENGLEWOOD,  CO  80112 -4271
Applicant Contact DEAN S LEWIS
Correspondent
PURE WATER SOLUTIONS, INC.
14550 EAST EASTER AVE., #800
ENGLEWOOD,  CO  80112 -4271
Correspondent Contact DEAN S LEWIS
Regulation Number876.5665
Classification Product Code
FIP  
Date Received12/20/1999
Decision Date 12/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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