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510(k) Data Aggregation

    K Number
    K211728
    Device Name
    Sterile hypodermic syringes for single use
    Date Cleared
    2021-10-05

    (123 days)

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

    Jiangsu Kangyou Medical Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sterile hypodermic syringes for single use are intended to inject fluids into or withdraw fluids from the body.
    Device Description
    The Sterile hypodermic syringes for single use are intended for manual and single use only to aspirate and inject of fluids for medical purpose, and consist of syringe (barrel, plunger, piston) and hypodermic needle (needle tube, hub, needle cap). The proposed device is available in a variety of syringe and needle sizes.
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