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

    EPI 2

    K Number: K935706 · Decision Feb 11, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    24
    Applicant Total
    1
    Review Days
    1169

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    Basic Information

    Device Name
    EPI 2
    K Number
    K935706
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.5360
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Universal H.R. System, Inc.
    Date Received
    November 30, 1993
    Decision Date
    February 11, 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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