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510(k) Data Aggregation

    K Number
    K101629
    Device Name
    FIL 1520
    Manufacturer
    GLENN MEDICAL SYSTEMS, INC.
    Date Cleared
    2010-07-09

    (29 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLENN MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Glenn Medical oxygen concentrator filter model FIL 1520 is intended to help remove air-borne contaminants, including air borne bacteria and other particulate debris from the air stream of an oxygen concentrator. The device is only used for Invacare Oxygen Concentrator.
    Device Description
    Glenn Oxygen Concentrator Filter, model FIL 1520
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