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510(k) Data Aggregation

    K Number
    K143497
    Device Name
    Safety Auto-Disable Syrine with Needle (Auto-Lock)
    Manufacturer
    GUANGDONG INTMED MEDICAL APPLIANCE CO., LTD
    Date Cleared
    2015-11-04

    (330 days)

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

    GUANGDONG INTMED MEDICAL APPLIANCE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Safety Auto-Disable Syringe with Needle (Auto-Lock) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy. It has a detachable needle with a dedicated fitting. The Safety Auto-Disable Syringe with Needle (Auto-Lock) contains an inner mechanism used to allow the needle to be retracted inside the plunger rod 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
    The proposed device is a single use, sterile syringe composed of barrel, plunger, plunger, push-button, spring, spring holder, rubber stopper, needle cap, and autodisable part.
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