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510(k) Data Aggregation

    K Number
    K110994
    Device Name
    PARKER 500
    Manufacturer
    ARJOHUNTLEIGH INC
    Date Cleared
    2011-07-06

    (89 days)

    Product Code
    ILJ, TRA
    Regulation Number
    890.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARJOHUNTLEIGH INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.
    Device Description
    The bathing system consists of a tub composed of fiberglass, which is covered by a panel containing all the integrated technical controls of the system. The bathing system is offered with or without a tub height positioning system, tub tilt system, hydro massage and an integrated disinfection system. The bathing system is not a sterile device.
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