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510(k) Data Aggregation
K Number
K010607Manufacturer
Date Cleared
2001-11-28
(272 days)
Product Code
Regulation Number
876.5130Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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