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

    OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR

    K Number: K871074 · Decision Apr 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    65
    Applicant Total
    5
    Review Days
    23

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    Basic Information

    Device Name
    OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR
    K Number
    K871074
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Omega Silicone, Inc.
    Date Received
    March 18, 1987
    Decision Date
    April 10, 1987
    Product Code
    FWP
    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
    FWP Prosthesis, Chin, Internal

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    Other Clearances by Omega Silicone, Inc.

    K Number Device Name
    K871072 OMEGA NASAL SEPTAL BUTTON
    K871070 OMEGA SILICONE CHIN IMPLANT
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