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

    EPILATOR, EASE-MULTI-MODE

    K Number: K781147 · Decision Oct 10, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    42
    Applicant Total
    1
    Review Days
    92

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    Basic Information

    Device Name
    EPILATOR, EASE-MULTI-MODE
    K Number
    K781147
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.5350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Greenleaf-Carter Enterprises, Inc.
    Date Received
    July 10, 1978
    Decision Date
    October 10, 1978
    Product Code
    KCW
    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
    KCW Epilator, High Frequency, Needle-Type

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