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510(k) Data Aggregation

    K Number
    K182582
    Device Name
    Oryum and Ovem Epidermal Deri Prick Test Applicator
    Manufacturer
    Allergy & Applicator Depot, LLC
    Date Cleared
    2019-04-10

    (203 days)

    Product Code
    SCL, LDH
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Allergy **& Applicator Depot, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oryum and Ovem Epidermal Skin Prick Test Applicator is used for the percutaneous administration of diagnostic allergenic extracts.
    Device Description
    Oryum and Ovem Epidermal Skin Prick Test Applicator is a sterile, disposable, multiple test head applicator used to administer skin test substances to the surface of the skin. The Oryum and Ovem Epidermal Skin Prick Test Applicator are used for the conventional percutaneous application of substance directly onto the surface of the skin of diagnostic allergen extracts for performing skin tests for hypersensitivity reactions in individuals suspected of having allergies. The Oryum and Ovem Epidermal Skin Prick Test Applicator is offered in several configurations with 1 to 12 test heads arranged in an asymmetrical design. Each of the test heads have a "leg." At the tip of each leg is an array of protruding test points (tines). The tines utilize capillary action to hold the allergenic material for percutaneous delivery when the applicator is applied to the skin. This is an industry wide standard design. The test heads are designed to fit into the matching asymmetrical well design of a dipwell tray. The applicator loads the allergen from each well in the tray on to each test head. When properly applied to the skin, the applicator will leave visible indentations in the patient's skin corresponding to the test heads of each applicator is not intended to pierce the skin.
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    K Number
    K992702
    Device Name
    EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
    Manufacturer
    ALLERGY DIRECT
    Date Cleared
    1999-11-08

    (88 days)

    Product Code
    FMW
    Regulation Number
    880.6190
    Why did this record match?
    Applicant Name (Manufacturer) :

    **ALLERGY **DIRECT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    eVENT™ Allergen Barriers have been designed exclusively for allergy sufferers wishing to reduce their exposure to house dust mite allergens in mattresses, pillows and duvel/comforters.
    Device Description
    eVENT™ Allergen Barriers consist of mattress, pillow and duvet/comforter encasings. The products consist of an expanded PTFE membrane laminated to a synthetic or synthetic/natural combination fabric. The expanded PTFE membrane provides a moisture-vapor & air permeable ("breathable") barrier with pores too small to allow passage to either house dust mites or their allergen containing fecal droppings. The fabric component provides a strong, easily maintained support for the ePTFE membrane. EVENT™ Allergen Barrlers are soft, comfortable and easy to clean; They are simply damp-dusted when the bed sheets are changed. Allergydirect.com's membrane manufacturing process is sufficiently controlled to ensure uniform nominal pore sizes too small to permit the Allergen Barners provide high levels of protection from house dust mite allergens. The membrane's vapor permeable characteristics help promote sleeping comfort. Thus, eVENT™ Allergen Barriers serve as an effective barrier between a patient and a cause of their allergies; this results in a healthier, more comfortable sleeping environment.
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