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510(k) Data Aggregation

    K Number
    K091719
    Device Name
    NEOSALUS LOTION
    Manufacturer
    QUINNOVA PHARMACEUTICALS
    Date Cleared
    2009-07-30

    (49 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUINNOVA PHARMACEUTICALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NEOSALUS Lotion is indicated for management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.
    Device Description
    NEOSALUS Lotion is fragrance-free, water-soluble dressing formulated for the management and relief of irritation experienced with various types of dermatoses including atopic dermatitis and allergic contact dermatitis. NEOSALUS Lotion is intended for topical application.
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    K Number
    K090585
    Device Name
    NEOSALUS CREAM
    Manufacturer
    QUINNOVA PHARMACEUTICALS
    Date Cleared
    2009-04-02

    (29 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUINNOVA PHARMACEUTICALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NEOSALUS Cream is indicated for management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.
    Device Description
    NEOSALUS Cream is fragrance-free, water-soluble dressing formulated for the management of various types of dermatoses including atopic dermatitis and allergic contact dermatitis. NEOSALUS Cream is intended for topical application.
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    K Number
    K070309
    Device Name
    NEOSALUS
    Manufacturer
    QUINNOVA PHARMACEUTICALS
    Date Cleared
    2008-09-12

    (589 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUINNOVA PHARMACEUTICALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Neosalus is indicated for management and relief of irritation associated with various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.
    Device Description
    Neosalus is fragrance-free, water-soluble foam dressing formulated for the management and relief of irritation experienced with various types of dermatoses including atopic dermatitis and allergic contact dermatitis. Neosalus is intended for topical application.
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    Ask a specific question about this device

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