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510(k) Data Aggregation

    K Number
    K090117
    Device Name
    AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET
    Manufacturer
    AUTOSAFE-REFLEX INC.
    Date Cleared
    2009-09-29

    (251 days)

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

    AUTOSAFE-REFLEX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AutoSafe Safety Huber Infusion Set is intended for use in the administration of fluids and drugs as well as blood sampling through implantable vascular ports Additionally, the passine needle safety shield is designed to help prevent needlestick injuries by shielding the needle between steps and after use.
    Device Description
    Not Found
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