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510(k) Data Aggregation
K Number
K954302Device Name
VYGON PREMI-CATH - LONG TERM CATHETERManufacturer
Date Cleared
1996-06-17
(278 days)
Product Code
Regulation Number
880.5970Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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