BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ZARA ZONE IV MALAR IMPLANT MODIFICATION

    K Number: K934233 · Decision Feb 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    39
    Applicant Total
    27
    Review Days
    157

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    Basic Information

    Device Name
    ZARA ZONE IV MALAR IMPLANT MODIFICATION
    K Number
    K934233
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Byron Medical
    Date Received
    August 30, 1993
    Decision Date
    February 3, 1994
    Product Code
    LZK
    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
    LZK Implant, Malar

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