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

    DEBUTRON

    K Number: K782119 · Decision Feb 26, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    24
    Applicant Total
    1
    Review Days
    61

    Basic Information

    Device Name
    DEBUTRON
    K Number
    K782119
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.5360
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    MARTIN ELECTRIC CO.
    Date Received
    December 27, 1978
    Decision Date
    February 26, 1979
    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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