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510(k) Data Aggregation

    K Number
    K090383
    Device Name
    SRI LEVEL II SURGICAL GOWN
    Manufacturer
    SRI SURGICAL
    Date Cleared
    2009-05-29

    (101 days)

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

    SRI SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SRI Level II Surgical Gown is a reusable surgical gown 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
    SRI Level II Surgical Gown SRI Part Numbers of various sizes: 7001, 7002, 7003, 7004, 7005
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