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510(k) Data Aggregation
K Number
K954969Device Name
POLYFIN QR SUBCUTANEOUS INFUSION SETManufacturer
Date Cleared
1996-02-22
(115 days)
Product Code
Regulation Number
880.5440Type
TraditionalPanel
General HospitalReference & 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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