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510(k) Data Aggregation
K Number
K000824Device Name
PERCUTANEOUS INTRODUCER, MODEL 10383-XXXManufacturer
Date Cleared
2000-04-13
(30 days)
Product Code
Regulation Number
870.1340Type
SpecialPanel
Cardiovascular (CV)Reference & Predicate Devices
N/A
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Device Name :
PERCUTANEOUS INTRODUCER, MODEL 10383-XXX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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