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510(k) Data Aggregation

    K Number
    K041224
    Device Name
    FOOTHILLS SURGICAL DRAPES
    Date Cleared
    2005-02-03

    (269 days)

    Product Code
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOOTHILLS INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Foothills Surgical Drapes are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination and to cover accessories in the operating room. These disposable single-use drapes are designed to be repackaged and sterilized before use by the user using a 100% EtO cycle that has been validated to achieve a SAL of 10-6 in accordance with ANSI/AAMI/ISO 11135:1994. Sterilization residual limits should meet the requirements of the ANSI/AAMI/ISO 10993-9:1995.
    Device Description
    Foothills Industries disposable surgical drapes and utility covers are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings.
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