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510(k) Data Aggregation

    K Number
    K243412
    Device Name
    ARCHIMEDES Biodegradable Pancreatic Stent
    Manufacturer
    Q3 Medical USA, LLC (c/o Q3 Medical Devices Ltd.)
    Date Cleared
    2025-07-16

    (257 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Q3 Medical USA, LLC (c/o Q3 Medical Devices Ltd.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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