BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    FINALLY FREE

    K Number: K972695 · Decision Oct 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    24
    Applicant Total
    1
    Review Days
    96

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    Basic Information

    Device Name
    FINALLY FREE
    K Number
    K972695
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.5360
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mehl/Group Marketing
    Date Received
    July 18, 1997
    Decision Date
    October 22, 1997
    Product Code
    KCX
    Advisory Committee
    General, Plastic Surgery
    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
    KCX Epilator, High Frequency, Tweezer-Type

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