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510(k) Data Aggregation

    K Number
    K052667
    Device Name
    ARTSANA PISTON AND INSULIN SYRINGES
    Manufacturer
    ARTSANA S.P.A.
    Date Cleared
    2005-11-25

    (59 days)

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

    ARTSANA S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Artsana disposable sterile insulin syringes are intended for subcutaneous injection of insulin.
    Device Description
    Not Found
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    K Number
    K051783
    Device Name
    ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES
    Manufacturer
    ARTSANA S.P.A.
    Date Cleared
    2005-10-04

    (95 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARTSANA S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Artsana disposable sterile hypodermic needles are intended for use to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Artsana disposable sterile pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.
    Device Description
    Not Found
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