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510(k) Data Aggregation

    K Number
    K192194
    Device Name
    TotalShield II Surgical Helmet System
    Manufacturer
    Zimmer Surgical, Inc
    Date Cleared
    2019-10-15

    (63 days)

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

    Zimmer Surgical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TotalShield II Zippered Surgical Toga and /or TotalShield II Surgical Hood is for use with the TotalShield II Surgical Helmet and/or TotalShield 11 Surgical Helmet with LED Lighting as the TotalShield II Surgical Helmet System that is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
    Device Description
    TotalShield II Surgical Helmet System
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