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

    OMEGA DORSAL COLUMELLA IMPLANTS

    K Number: K871071 · Decision Apr 13, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    41
    Applicant Total
    5
    Review Days
    26

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    Basic Information

    Device Name
    OMEGA DORSAL COLUMELLA IMPLANTS
    K Number
    K871071
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Omega Silicone, Inc.
    Date Received
    March 18, 1987
    Decision Date
    April 13, 1987
    Product Code
    FZE
    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
    FZE Prosthesis, Nose, 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
    K871073 OMEGA BIVALVE NASAL SPLINTS
    K871074 OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR