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510(k) Data Aggregation

    K Number
    K061422
    Device Name
    SURGICAL DRAPES
    Manufacturer
    AUSTIN MEDICAL, INC.
    Date Cleared
    2006-09-25

    (125 days)

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

    AUSTIN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical drapes 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. These are provided non-sterile to kit packers, who then may sterilize the drape as part of a kit.
    Device Description
    Various types of surgical drapes
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