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510(k) Data Aggregation

    K Number
    K954717
    Device Name
    SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY
    Manufacturer
    SODEM DIFFUSION SA
    Date Cleared
    1997-01-22

    (467 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    SODEM DIFFUSION SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SODEM HIGH SPEED SYSTEM (with associated accessories/attachments) is intended for use for neurosurgery (spine and craniotomy) and median sternotomy.
    Device Description
    The SODEM HIGH SPEED SYSTEM is a modular, pneumatic, high speed instrument system consisting of a handpiece and accessories/attachments (including but not limited to adapter, spindles, and burrs).
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    K Number
    K955174
    Device Name
    SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY
    Manufacturer
    SODEM DIFFUSION SA
    Date Cleared
    1996-01-22

    (70 days)

    Product Code
    GET
    Regulation Number
    878.4820
    Why did this record match?
    Applicant Name (Manufacturer) :

    SODEM DIFFUSION SA

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

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