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510(k) Data Aggregation
Device Name
FOGARTY VALVULOTOME, MODEL 700091Manufacturer
Date Cleared
2001-03-26
(292 days)
Product Code
Regulation Number
870.4885Type
TraditionalPanel
CardiovascularAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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