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510(k) Data Aggregation

    K Number
    K060668
    Device Name
    SAFE TIP SYRINGE
    Date Cleared
    2006-06-12

    (90 days)

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

    DEVON SAFETY PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Devon SafeTip Safety Syringe is indicated for use in the administration of an intramuscular (IM) injection. The SafeTip Safety Syringe aids in the prevention of accidental needle sticks by passively and automatically deploying a sheath that covers the sharp needle upon completion of the injection.
    Device Description
    The SafeTip Safety Syringe is a piston syringe that features a passive sharp safety feature which covers the needle after injection. The syringe automatically deploys a plastic cover (sheath) over the needle as the injection is completed and prior to the needle's removal from the tissue. The sheath protrudes beyond the end of the needle, shielding the user and patient from the sharp needle after removal.
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    K Number
    K052551
    Device Name
    DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE
    Date Cleared
    2005-09-30

    (14 days)

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

    DEVON SAFETY PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended for injection of fluids into, or withdrawing fluids from, parts of the body below the surface of the skin. Syringe with plunger for general medical uses. The Insulin syringes are intended for insulin injection.
    Device Description
    The Devon Standard Syringe is a sterile, single use, disposable syringe with attachable hypodermic needle. The Devon Standard Syringe consists of a syringe barrel, a plunger rod, piston, nozzle cap and a single lumen hypodermic needle. The Insulin syringes are used for the injection of U100 insulin only and have scale lines in insulin units.
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