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Found 3 results
510(k) Data Aggregation
K Number
K982378Device Name
HEMSOL-ACID CONCENTRATE LIQUID HEMOGRAN ACID CONCENTRATE POWDER, NEPHROSOL-ACETATE CONCENTRATE POWDER, BICARBOSOL-BICARE
Manufacturer
SOLUTION TECHNOLOGIES
Date Cleared
1998-08-26
(49 days)
Product Code
KPO
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
SOLUTION TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This concentrate is formulated to be used with a two stream hemodialysis machine Calibrated to an acetate Concentration dilution ratio of 1:34
Device Description
Not Found
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K Number
K981043Device Name
DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL
Manufacturer
SOLUTION TECHNOLOGIES
Date Cleared
1998-05-26
(67 days)
Product Code
KPO
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
SOLUTION TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THIS CONCENTRATE IS FORMULATED TO BE USED WITH A THREE STREAM HEMODIALYSIS MACHINE WHICH IS CALIBRATED FOR ACID AND BICARBONATE CONCENTRATES.
THIS CONCENTRATE IS FORMULATED TO BE USED WITH A TWO STREAM HEMODIALYSIS MACHINE CALIBRATED TO AN ACETATE CONCENTRATED DILUTION RATIO OF 1:34
THIS CONCENTRATE IS FORMULATED TO BE USED WITH A THREE STREAM HEMODIALYSIS MACHINE WHICH IS CALIBRATED FOR ACID AND BICARBONATE CONCENTRATES.
Device Description
Dialysol, Granusol, Renalsol and Biosol Liquid and Powder Dialysate Concentrate
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K Number
K961409Device Name
PORTA'PURE/DENTAL
Manufacturer
WATER SOLUTION TECHNOLOGIES
Date Cleared
1996-06-12
(62 days)
Product Code
EIA
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
WATER SOLUTION TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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