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510(k) Data Aggregation
K Number
K955722Device Name
FLEXON TEMPORARY CARDIAC PACER LEADManufacturer
Date Cleared
1996-03-15
(88 days)
Product Code
Regulation Number
870.3680Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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