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510(k) Data Aggregation

    K Number
    K083193
    Device Name
    REVAC AUTO RETRACTABLE SAFETY SYRINGE
    Date Cleared
    2009-02-13

    (107 days)

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

    REVOLUTIONS MEDICAL CORPORATION INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Reverse Vaccuum (RevVac) Safety Syringe, is a sterile, single use, disposable, autoretracting safety piston syringe which is intended for injection of fluid into the body, while reducing the risk of sharps injury and the potential for syringe reuse. The device is intended for use for subcutaneous and intramuscular use.
    Device Description
    The ReVac (Reverse Vacuum) Safety Syringe is a piston type hypodermic syringe with an automated needle retraction system. The device works like a typical syringe in that after removal of the cap, the user pulls back the syringe to feed liquid back into the barrel. Once the plunger is fully depressed, and the fluid inside is fully dispensed, a vacuum is created that is sufficient to force the retraction of the needle into the hollow chamber of the syringe. The needle is not visible and is fully inaccessible. The needle cannot be removed from the syringe without completely destroying the syringe. The ReVac (Reverse Vacuum) Safety Syringe is a piston type hypodermic syringe with an automated needle retraction system. It is sterile, non-toxic, non-pyrogenic, retractable syringe designed to provide a safe reliable method for intramuscular and subcutaneous injection of drugs and or fluids while helping to provide protection from accidental needle sticks.
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