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510(k) Data Aggregation

    K Number
    K213077
    Device Name
    Automatically Retractable Safety Syringe
    Manufacturer
    Zhejiang Lingyang Medical Apparatus Co., Ltd.
    Date Cleared
    2022-04-27

    (216 days)

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

    Zhejiang Lingyang Medical Apparatus Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Automatically Retractable Safety Syringe is used for aspiration of fluids from vials and a variety of fluid injections into the human body through subcutaneous and muscle. It has a detachable needle with a dedicated fitting. The Automatically Retractable Safety Syringe contains an inner mechanism used to allow the needle to be retracted inside the plunger of the syringe after the operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
    Device Description
    Automatically Retractable Safety Syringe
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