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510(k) Data Aggregation

    K Number
    K010616
    Device Name
    DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A
    Date Cleared
    2001-03-28

    (27 days)

    Product Code
    Regulation Number
    880.5045
    Why did this record match?
    Applicant Name (Manufacturer) :

    HMI INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K002692
    Device Name
    DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A
    Date Cleared
    2000-11-17

    (80 days)

    Product Code
    Regulation Number
    880.5045
    Why did this record match?
    Applicant Name (Manufacturer) :

    HMI INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

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