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510(k) Data Aggregation

    K Number
    K050999
    Device Name
    YI XIN STERILE SYRINGE FOR SINGLE USE
    Manufacturer
    JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP
    Date Cleared
    2005-09-02

    (135 days)

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

    JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    YI XIN Sterile Syringe for Single Use is a sterile, single-use, disposable and nonreusable syringe intended for injection of fluids into or withdraw fluids from the body.
    Device Description
    Not Found
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    K Number
    K042102
    Device Name
    YIXIN SAFETY SYRINGE
    Manufacturer
    JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP
    Date Cleared
    2005-03-08

    (216 days)

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

    JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    YI XIN Safety Syringe is a sterile, single-use, disposable and nonreusable, manual retractable safety syringe intended for injection of fluids into or withdraw fluids from the body, while reducing the risk of sharps injuries and the potential for syringe reuse. The safety syringes are for IV and IM use.
    Device Description
    Not Found
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