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510(k) Data Aggregation

    K Number
    K050188
    Device Name
    EPIGUARD
    Manufacturer
    EPISAFE MEDICAL DEVICES, LTD.
    Date Cleared
    2005-04-27

    (90 days)

    Product Code
    JXL
    Regulation Number
    882.5070
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPISAFE MEDICAL DEVICES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EpiGuard is intended for the prevention of oral soft tissue damage during epileptic tonic-clonic seizures proceeded by an aura.
    Device Description
    The EpiGuard is a single use oral protective device manufactured from biocompatible silicone. It is provided clean (non-sterile). Besides providing a physical barrier to prevent tongue and cheek damage of the user, the device will maintain an open airway in the mouth cavity and allow the free flow of air and vomit. In addition, the device is griped under the palatals and teeth of the user while also being held in front by the interior surface of the lips. This allows the EpiGuard to be fixed to the necessary position to prevent it from being swallowed.
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