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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tank, Holding, Dialysis
510(k) Number K993272
Device Name PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
Applicant
PURE WATER, INC.
305 WEST MARKET ST.
ANDERSON,  SC  29624
Applicant Contact CYNTHIA P WALTERS
Correspondent
PURE WATER, INC.
305 WEST MARKET ST.
ANDERSON,  SC  29624
Correspondent Contact CYNTHIA P WALTERS
Regulation Number876.5820
Classification Product Code
FIN  
Subsequent Product Code
KPO  
Date Received09/30/1999
Decision Date 04/10/2000
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
Recalls CDRH Recalls
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