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510(k) Data Aggregation

    K Number
    K041978
    Device Name
    REPROCESSED DIAMOND BURS
    Date Cleared
    2004-11-23

    (123 days)

    Product Code
    Regulation Number
    882.4310
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    Product Code :

    NLN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Reprocessed Diamond Burs are indicated for use in patients requiring surgery involving bone and bony structures.
    Device Description
    Diamond Burs are specially designed surgical accessories designed to help the surgeon cut and drill bone and bony structures during orthopedic procedures.
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