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510(k) Data Aggregation

    K Number
    K051426
    Device Name
    CARLO SURGICAL GOWN
    Manufacturer
    SOFILM TECHNOLOGY CO., LTD.
    Date Cleared
    2005-08-02

    (62 days)

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

    SOFILM TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sofilm Technology Co., Ltd. Carlo Surgical Gown is a sterile, single-use surgical gown that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
    Device Description
    Carlo Surgical Gown. Disposable, Sterile
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