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510(k) Data Aggregation

    K Number
    K043419
    Device Name
    P&P SAFETY SYRINGE
    Date Cleared
    2005-04-15

    (123 days)

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

    MEDEXEL MEDICAL MFG. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    The p&p Safety Syringe consists of a calibrated hollow barrel (which can contain the medication) and the distal end of the barrel has Luer Lock Tip. The needle can be changed depending on the required gauge, since the syringe is compatible with general needles. The Safety Cap can be moved back and forth as safety feature. The safety cap has a printing mark "LOCK LINE". The adaptor is colored with medical grade blue pigment . The plunger and gasket are the same shape as the conventional syringes. When user gives the intramuscular/subcutaneous injection, he/she pushes the knob of the plunger to the end. After completing the intramuscular/ subcutaneous injection, the user turns the safety cap to the left side, and then pushes it forward until the marking ("LOCK LINE") on the safety cap touches the bottom line of the blue adaptor in order to lock the safety cap and the adaptor. The blue color of the adaptor allows the user to distinguish the locking position clearly and easily. Then the safety cap can no longer be moved back and forth, thus preventing needlestick injury. Then the syringe can be disposed in the appropriate sharps container. This is a simple and elegant design which is highly reliable.
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