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510(k) Data Aggregation

    K Number
    K071567
    Device Name
    AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE
    Date Cleared
    2007-09-14

    (99 days)

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

    AUTOSAFE-REFELX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AutoSafe Safety Needles are indicated to be used to inject fluids into or withdraw fluid from the body. They are compatible for use with standard luer slip and luer lock syringes. Additionally, the passive needle safety shield is designed to help prevent needlestick injuries by shielding the needle before use, between steps and after use.
    Device Description
    Not Found
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