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510(k) Data Aggregation

    K Number
    K960473
    Device Name
    AESCULAP POWER SYSTEM HANDPIECE
    Manufacturer
    AESCULAP, INC.
    Date Cleared
    1996-03-07

    (35 days)

    Product Code
    GET
    Regulation Number
    878.4820
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    Product Code :

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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Power System Handpiece is intended for use for holding and delivering power to surgical accessories (i.e. burrs, drills).
    Device Description
    Aesculap's modified Power System Handpiece is a stainless steel device used for holding and delivering power to surgical accessories (i.e. burrs, drills.) The device has an overall length of 230 mm with a shaft angle of 21°. The handpiece holds drills and burrs with a shank diameter of 2.35 mm and a length of 180 mm. The device is connected to an electro-surgical motor unit via a power drive cable. The Power System Handpiece is compatible with Aesculap's Elan-E and Microtron power units. The Internal gear ratio is 1:2, allowing the device to run at speeds of 0-36,000 rpm with the Elan-E and 0-54,000 rpm with the Microtron power unit.
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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?
    Product Code :

    GET

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

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