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510(k) Data Aggregation

    K Number
    K040772
    Device Name
    PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
    Manufacturer
    PENNER MANUFACTURING, INC.
    Date Cleared
    2004-04-05

    (10 days)

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

    PENNER MANUFACTURING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pacific Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only. The Pacific Bath will not be marketed for therapeutic or other medical uses.
    Device Description
    Pacific Recumbent Height Adjustable Bath
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    K Number
    K012057
    Device Name
    CASCADE BATH, MODEL 6900
    Manufacturer
    PENNER MANUFACTURING, INC.
    Date Cleared
    2001-07-19

    (17 days)

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

    PENNER MANUFACTURING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cascade Bath is intended for bathing patients and/or residents in nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only.
    Device Description
    Not Found
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    K Number
    K012061
    Device Name
    SUPERIOR BATH, MODEL 6300
    Manufacturer
    PENNER MANUFACTURING, INC.
    Date Cleared
    2001-07-19

    (17 days)

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

    PENNER MANUFACTURING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Superior Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only.
    Device Description
    Superior Bath Model 6300
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