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510(k) Data Aggregation

    K Number
    K083686
    Device Name
    BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES
    Manufacturer
    ANHUI KANGDA MEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2009-07-02

    (202 days)

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

    ANHUI KANGDA MEDICAL PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the BAIXIN Disposable Syringe is to inject fluids into or withdraw fluids from the body.
    Device Description
    BAIXIN Disposable Syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer.
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    K Number
    K083687
    Device Name
    BAIXIN INTRAVASCULAR ADMINISTRATION SET
    Manufacturer
    ANHUI KANGDA MEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2009-06-11

    (181 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANHUI KANGDA MEDICAL PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
    Device Description
    BAIXIN™ Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. This device is sterile and for single use only.
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