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510(k) Data Aggregation

    K Number
    K212764
    Device Name
    Medwell Technology Ltd Syringes, various sizes
    Date Cleared
    2022-11-04

    (430 days)

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

    Medwell Technology Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medwell Technology Polycarbonate Syringes are intended to inject fluids into or withdraw fluids from the body.
    Device Description
    The Medwell Technology PC Syringes are provided sterile or in bulk non-sterile for further processing (e.g. sterilization). They are single use devices consisting of rigid polycarbonate barrels with luer slip or luer lock tips and various colored plungers with a synthetic rubber tip (stopper). The syringe barrels are printed with graduated markings in cc (1- 30 milliliters) indicating the volume of liquid inside the various size syringe barrels.
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