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

    OMEGA NASAL SEPTAL BUTTON

    K Number: K871072 · Decision Jun 8, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    5
    Review Days
    82

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    Basic Information

    Device Name
    OMEGA NASAL SEPTAL BUTTON
    K Number
    K871072
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Omega Silicone, Inc.
    Date Received
    March 18, 1987
    Decision Date
    June 8, 1987
    Product Code
    LFB
    Advisory Committee
    Unknown
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LFB Button, Nasal Septal

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    Other Clearances by Omega Silicone, Inc.

    K Number Device Name
    K871070 OMEGA SILICONE CHIN IMPLANT
    K871073 OMEGA BIVALVE NASAL SPLINTS
    K871071 OMEGA DORSAL COLUMELLA IMPLANTS
    K871074 OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR