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510(k) Data Aggregation

    K Number
    K031163
    Device Name
    SEZ SAFETY SYRINGE
    Manufacturer
    SEZ CORPORATION
    Date Cleared
    2003-07-08

    (85 days)

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

    SEZ CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.
    Device Description
    SEZ Safety Syringe consists of 1) a calibrated hollow barrel which contains medication and, after use, confines 2) the needle, 3) a movable plunger which aspirates medication and, after injection, retracts the needle into the barrel, At the distal end of the barrel, there is a female connector(nozzle) for fitting 3) a male connector(hub) to which the needle is firmly attached by bonding material. The needle is securely protected by 5) a cap before use. For sealing purpose, 6) an o-ring, between barrel and hub, and a gasket, between barrel and plunger, are used. The function of the device is to deliver medication and, after injection, to destroy the needle in the barrel to prevent needlestick injury and possible reuse. The injection process is practically the same as that of the conventional, non-safety, syringes, that is, to aspirate medication from a vial and to deliver it to a patient. The disposal process is turn-pull-push operation, each step of which is clearly and unmistakably defined. By turning the knob of the plunger half round clockwise, hub is disassembled from the barrel. Then plunger is pulled backward until it stops, which retracts hub and needle into the barrel. Needle is tilted to one-side pushed by the rod at plunger head. Finally, the plunger is pushed forward to crumble the needle in the barrel. Needle and contaminated fluid are contained in the barrel safely and used syringe can be discarded in the sharps container.
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