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510(k) Data Aggregation

    K Number
    K993501
    Device Name
    3D1 MICROPOSITIONING HEADSTAGE
    Date Cleared
    1999-11-22

    (38 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIENTIFIC TOOLS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 3D1 Micropositioning Headstage is indicated for use by a qualified neurosurgeon when precise movement of a surgical instrument is needed along any of three axes. The 3D1 Micropositioning Headstage is intended to be used with a standard stereotactic headframe system.
    Device Description
    The 3D1 Micropositioning Headstage is a device that allows for precise positioning of a neurosurgical instrument along three axes. The device is used in neurosurgical procedures in conjunction with a conventional stereotactic head frame and serves as an accessory to those devices. The 3D1 device comes with a mounting adaptor that is specific for the particular stereotactic head frame being used.
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