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510(k) Data Aggregation

    K Number
    K991989
    Device Name
    MITAKA POINT SETTER
    Manufacturer
    MITAKA USA, INC.
    Date Cleared
    1999-08-27

    (74 days)

    Product Code
    GWG
    Regulation Number
    882.1480
    Why did this record match?
    Applicant Name (Manufacturer) :

    MITAKA USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mitaka Point Setter is intended for use by qualified surgeons for holding rigid and flexible endoscopes during diagnostic and therapeutic neurologic procedures.
    Device Description
    The Mitaka Point Setter is a manual/pneumatic surgical device composed of materials commonly used in medical devices for a wide range of applications.
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    K Number
    K984355
    Device Name
    POINT SETTER
    Manufacturer
    MITAKA USA, INC.
    Date Cleared
    1999-04-01

    (115 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MITAKA USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The point setter is indicated for use as a holder for an endoscope.
    Device Description
    Not Found
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