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

    MONOJECT INSULIN SYRINGE

    K Number: K991758 · Decision Jun 14, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    63
    Review Days
    21

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    Basic Information

    Device Name
    MONOJECT INSULIN SYRINGE
    K Number
    K991758
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Kendal Co.
    Date Received
    May 24, 1999
    Decision Date
    June 14, 1999
    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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