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510(k) Data Aggregation
K Number
K002847Manufacturer
Date Cleared
2001-05-31
(260 days)
Product Code
Regulation Number
870.1340Type
AbbreviatedPanel
CardiovascularReference & Predicate Devices
N/A
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Device Name :
INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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