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

    NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY SYSTEM

    K Number: K872805 · Decision Oct 9, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    553
    Registration Numbers
    553
    Same Product Code
    738
    Applicant Total
    2
    Review Days
    86

    Basic Information

    Device Name
    NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY SYSTEM
    K Number
    K872805
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    SQUIBB-NOVO, INC.
    Date Received
    July 15, 1987
    Decision Date
    October 9, 1987
    Product Code
    FMF
    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
    FMF Syringe, Piston

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    Other Clearances by SQUIBB-NOVO, INC.

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