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510(k) Data Aggregation

    K Number
    K060002
    Device Name
    RITRACT SAFETY SYRINGE
    Manufacturer
    Date Cleared
    2006-06-02

    (150 days)

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

    RITRACT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ritract Safety Syringe is a sterile, single-use, disposable, nonreusable, auto-retracting safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injury and the potential for syringe reuse.
    Device Description
    The Ritract Safety Syringe is a sterile, single-use, disposable, nonreusable, 3mL, 5mL, 10ml, auto-retracting safety syringe with a standard luer lock needle connection.
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