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

    NARVAL CC

    K Number: K113201 · Decision Dec 1, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    31

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    Basic Information

    Device Name
    NARVAL CC
    K Number
    K113201
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Resmed Sas
    Date Received
    October 31, 2011
    Decision Date
    December 1, 2011
    Product Code
    LQZ
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LQZ Device, Jaw Repositioning

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