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510(k) Data Aggregation

    K Number
    K040545
    Device Name
    OTTER SAFETY SYRINGE
    Date Cleared
    2004-04-22

    (51 days)

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

    OTTER (CHINA) TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Otter Safety Syringe is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
    Device Description
    The Otter Safety Syringe is an integrated needle and piston syringe with an innovative anti-needlestick mechanism. The design incorporates the ideal features desired in a safety syringe. No special techniques meenanism. "The atternechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism clearly shows that the needle has been crushed within the syringe barrel. After standard techniques for injection, the plunger is withdrawn completely into the barrel. A forward compression of the plunger again and the needle is crushed within the puncture-resistant barrel. This renders the needle unusable and safe from accidental needle sticks.
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