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510(k) Data Aggregation

    K Number
    K012726
    Device Name
    PROSAFE SAFETY SYRINGE
    Manufacturer
    Date Cleared
    2001-10-18

    (64 days)

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

    HOU-SE MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A properly placed syringe provides access to a vein or tissue for fluid sampling or infusion. The safety syringe is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a needle retraction system which is activated after the infusion procedure is completed.
    Device Description
    The SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries.
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