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510(k) Data Aggregation

    K Number
    K141349
    Device Name
    Disposable sterile needle retractable safety syringe
    Date Cleared
    2015-04-10

    (323 days)

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

    GUANGDONG HAIOU MEDICAL APPARATUS STOCK CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable sterile needle retractable safety syringe is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into patient.
    Device Description
    Disposable sterile needle retractable safety syringe is a piston syringe. The device is intended for medical purposes and consists of a protective cover, Needle base, circle ring, Pull & back part, Piston, Plunger and barrel. The needle is fixed on the syringe. The device is used to inject fluids into the body. The subject device of Disposable sterile needle retractable safety syringe is available in 0.5ml, 1ml, 3ml, 5ml and 10 ml volumes. The subject device is provided sterilized. Disposable sterile needle retractable safety syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. After the injection is completed, the groove of the upper end of the plunger locks the needle. The plunger is retracted completely after the injection. The needle is retracted completing into the barrel of the syringe.
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