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510(k) Data Aggregation

    K Number
    K221777
    Device Name
    Disposable Sterile Syringe
    Date Cleared
    2023-10-06

    (472 days)

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

    Weihai Shengjie Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable Sterile Syringe is intended to inject fluids into or withdraw fluids from the body.
    Device Description
    Disposable Sterile Syringe, is a plastic syringe designed for intended to inject fluids into or withdraw fluids from the body. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a barrel, plunger, Piston, Needle tube, Needle hub and Needle cap. All specifications of product subject to the same design and the difference between each specification is syringe volume and needle size. The product is available in a variety combination of needle size and syringe volume.
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