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510(k) Data Aggregation

    K Number
    K022260
    Device Name
    FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS
    Date Cleared
    2002-08-29

    (62 days)

    Product Code
    Regulation Number
    880.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISOLATION SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For Transporting and Isolating a TB patient or a suspected TB patient
    Device Description
    Not Found
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