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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 K993058
Device Name PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL
Applicant
Pure Water, Inc.
305 W. Market St.
Anderson,  SC  29624
Applicant Contact RHONDA S MCCOY
Correspondent
Pure Water, Inc.
305 W. Market St.
Anderson,  SC  29624
Correspondent Contact RHONDA S MCCOY
Regulation Number876.5820
Classification Product Code
FIN  
Subsequent Product Code
KPO  
Date Received09/13/1999
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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