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

    OMEGA BIVALVE NASAL SPLINTS

    K Number: K871073 · Decision May 11, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    5
    Review Days
    54

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    Basic Information

    Device Name
    OMEGA BIVALVE NASAL SPLINTS
    K Number
    K871073
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.3250
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Omega Silicone, Inc.
    Date Received
    March 18, 1987
    Decision Date
    May 11, 1987
    Product Code
    FYI
    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
    FYI Appliance, Facial Fracture, External

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    Other Clearances by Omega Silicone, Inc.

    K Number Device Name
    K871072 OMEGA NASAL SEPTAL BUTTON
    K871070 OMEGA SILICONE CHIN IMPLANT
    K871071 OMEGA DORSAL COLUMELLA IMPLANTS
    K871074 OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR