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510(k) Data Aggregation
K Number
K991916Device Name
VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Manufacturer
Date Cleared
2000-01-14
(221 days)
Product Code
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
VIRGINIA WATER SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Virginia Water Systems' Water Purification for Hemodialysis is intended to remove organic, inorganic, and microbial contaminants from water used to make dialysate and reprocess dialyzers as well as rinsing and disinfection of the dialysis equipment. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.
Device Description
Virginia Water Systems' Water Purification for Hemodialysis is complete water treatment system used in the production of ultrapure water used in hemodialysis facilities. The components consist of the following: Blend Valve, Inlet Booster Pump, Multimedia Filter, Softener, Carbon Tanks, Reverse Osmosis Unit, Water Storage Tank, Repressure Pumps, Deionizer, Ultraviolet Light, Submicron Filter, Hollow Fiber Filter.
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