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510(k) Data Aggregation

    K Number
    K013846
    Device Name
    ULTRAGARD IMPERVIOUS REINFORCED GOWN
    Manufacturer
    PRECEPT MEDICAL PRODUCTS, INC.
    Date Cleared
    2002-05-22

    (183 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECEPT MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is indicated for use in operating room procedures as a sterile cover garment.
    Device Description
    The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is composed of a single base layer of SMS non-woven material with reinforced areas of the chest and sleeves. The reinforced area contains an additional layer of polyester laminated to a film.
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