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

    MODEL SE-5 EPILATOR

    K Number: K893389 · Decision Jun 5, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    42
    Applicant Total
    13
    Review Days
    35

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    Basic Information

    Device Name
    MODEL SE-5 EPILATOR
    K Number
    K893389
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.5350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    R. A. Fischer Co. Corp.
    Date Received
    May 1, 1989
    Decision Date
    June 5, 1989
    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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