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510(k) Data Aggregation
K Number
K010760Manufacturer
Date Cleared
2001-06-11
(90 days)
Product Code
Regulation Number
876.5820Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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