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510(k) Data Aggregation

    K Number
    K980053
    Device Name
    GLENROE CHAIN
    Manufacturer
    GLENROE TECHNOLOGIES
    Date Cleared
    1998-02-24

    (49 days)

    Product Code
    ECI
    Regulation Number
    872.5410
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLENROE TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use to connect brackets and help to close gaps between teeth. They are normally used for a period of 4 to 6 weeks, then replaced with new chain.
    Device Description
    Glenroe Glow-In-Dark Elastomeric Ligature Chain
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