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    K Number
    K160569
    Device Name
    NeuGuide
    Manufacturer
    POP Medical Solutions
    Date Cleared
    2016-07-06

    (128 days)

    Product Code
    PBQ
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    POP Medical Solutions

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NeuGuide is indicated for attaching sutures to ligaments of the pelvic floor.
    Device Description
    The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor. It is a single use instrument, supplied sterile and pre-loaded. The NeuGuide device comprises three elements, the anchor-suture unit, an applicator, and a thimble with work channel.
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