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510(k) Data Aggregation

    K Number
    K200977
    Device Name
    Modular Toga
    Manufacturer
    Operating Room Innovations, Inc.
    Date Cleared
    2020-08-05

    (114 days)

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

    Operating Room Innovations, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Operating Room Innovation's Modular Toga are components of a personal protection system and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.
    Device Description
    Modular Toga
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