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510(k) Data Aggregation

    K Number
    K162525
    Device Name
    Oniko nail brace
    Date Cleared
    2018-04-25

    (593 days)

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

    BEGUM SAGLIK HIZMETLERI TIBBI MALZEMELER DANISMANLIK LSTI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To correct the shape of overcurved and/or painful nails without operation. To loosen and to give shape to thickened nails, overcurved nails and pincer nails without operation.
    Device Description
    Oniko nail brace is a device for correcting the shape for painful and/or overcurved nails without the use of any operation or anesthesia. Oniko nail brace is composed of metal hooks and silicone bands. The metal hooks grasp the nail sides open to correct the shape or painful and/or overcurved nails.
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