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510(k) Data Aggregation

    K Number
    K980909
    Device Name
    VICHY SHOWER
    Date Cleared
    1998-08-11

    (154 days)

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

    BOUVIER HYDRO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Vichy Shower is used in hydrotherapy 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
    Not Found
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    K Number
    K980920
    Device Name
    EQUINOXE
    Date Cleared
    1998-07-16

    (128 days)

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

    BOUVIER HYDRO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Relieve pain and itching, as an aid in the healing process of inflamed and traumatized tissue, and serve as a settting for removal of contamined tissue.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

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