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510(k) Data Aggregation

    K Number
    K210991
    Device Name
    Disposable Sterile Syringe, Disposable Sterile Syringe with Needle
    Date Cleared
    2021-08-26

    (146 days)

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

    Guangdong Antmed Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Sterile Syringe with Needle is intended for use in the aspiration of fluids for medical purpose. The Disposable Sterile Syringe is a sterile luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.
    Device Description
    The proposed devices are provided in two types of configurations: - i. a disposable sterile syringe with sterile hypodermic needle contained in a blister packaging made of PP/PE composite film and coated paper sealed by hot sealing - ii. a disposable sterile syringe contained in a blister packaging made of PP/PE composite film and coated paper sealed by hot sealing The disposable sterile syringe with needle is manually operated and intended for single use only, which consists of a needle and a luer lock syringe. The disposable sterile syringe consists of barrel, plunger and piston. The proposed device is available in various combination of syringe volume and needle size.
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