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

    LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT

    K Number: K011554 · Decision Jun 26, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    16
    Applicant Total
    441
    Review Days
    39

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    Basic Information

    Device Name
    LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
    K Number
    K011554
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet, Inc.
    Date Received
    May 18, 2001
    Decision Date
    June 26, 2001
    Product Code
    MIX
    Advisory Committee
    Ear, Nose, Throat
    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
    MIX System, Vocal Cord Medialization

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