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

    HUMAPEN LUXURA HD

    K Number: K063151 · Decision Jan 9, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    85

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    Basic Information

    Device Name
    HUMAPEN LUXURA HD
    K Number
    K063151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eli Lilly and Co.
    Date Received
    October 16, 2006
    Decision Date
    January 9, 2007
    Product Code
    NSC
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NSC Injector, Pen

    Other Clearances by Eli Lilly and Co.

    K Number Device Name
    K982842 HUMAPEN AND HUMAPEN ERGO