BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇹🇷 Türkiye

    Oniko nail brace

    K Number: K162525 · Decision Apr 25, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    593

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    Basic Information

    Device Name
    Oniko nail brace
    K Number
    K162525
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti
    Date Received
    September 9, 2016
    Decision Date
    April 25, 2018
    Product Code
    MQZ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQZ Prosthesis, Nail

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