BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    LUBRIGYN CREAM

    K Number: K132772 · Decision Aug 22, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    242
    Applicant Total
    2
    Review Days
    351

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    Basic Information

    Device Name
    LUBRIGYN CREAM
    K Number
    K132772
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Uniderm Farmaceutici Srl
    Date Received
    September 5, 2013
    Decision Date
    August 22, 2014
    Product Code
    NUC
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NUC Lubricant, Personal

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    Other Clearances by Uniderm Farmaceutici Srl

    K Number Device Name
    K150147 Lubrigyn cream