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510(k) Data Aggregation

    K Number
    K974672
    Device Name
    MSI SURGICAL DRAPES
    Manufacturer
    MEDICAL SPECIALTY INNOVATIONS, INC. (MSI)
    Date Cleared
    1998-03-13

    (88 days)

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

    MEDICAL SPECIALTY INNOVATIONS, INC. (MSI)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MSI Surgical Drapes are intended to be used as a protective patient drape during surgical procedures to isolate the site of the surgical incisions and assist in protecting the site from microbial and other contamination.
    Device Description
    Not Found
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    K Number
    K972117
    Device Name
    MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW
    Manufacturer
    MEDICAL SPECIALTY INNOVATIONS, INC. (MSI)
    Date Cleared
    1997-08-26

    (82 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL SPECIALTY INNOVATIONS, INC. (MSI)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MSI transfer devices are decanting devices intended for the asceptic dispensing of solutions from IV containers. Each device is used as follows VialFlow: used to dispense fluids from glass vials RapidFlow: used to dispense fluids from flexible bags BottleFlow: used to dispense fluids from Large Glass IV Bottles TransFlow: used to dispense fluids from small vial, or to transfer solutions from container to container
    Device Description
    The MSI transfer devices are one piece, injection molded transparent hollow tubes with one or more spiked ends. Some models have a splash guard. They are sterile, disposible devices.
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