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510(k) Data Aggregation

    K Number
    K161318
    Device Name
    Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
    Manufacturer
    TEDAN SURGICAL INNOVATIONS LLC
    Date Cleared
    2017-03-20

    (313 days)

    Product Code
    GZT
    Regulation Number
    882.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEDAN SURGICAL INNOVATIONS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Phantom™ Fukushima and Mastability Neurological Holding Systems are intended to provide access and allow visualization of the surgical field, and to retract soft tissue during neurological cranial procedures.
    Device Description
    Not Found
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