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510(k) Data Aggregation

    K Number
    K033166
    Device Name
    KACEY INSULIN SYRINGE
    Manufacturer
    KACEY, INC.
    Date Cleared
    2003-12-12

    (73 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    KACEY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This product is intended for use by individuals who have been directed by and are under the supervision of professional staff to use insulin injections as a means to control the effects of diabetes. The product is intended to be used in any setting that meets the needs of the user.
    Device Description
    Piston Syringe
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