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510(k) Data Aggregation

    K Number
    K093320
    Device Name
    DRYODINE CADEXOMER-IODINE GEL
    Manufacturer
    COLLEGIUM PHARMACEUTICAL INCORPORATED
    Date Cleared
    2010-06-18

    (238 days)

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

    COLLEGIUM PHARMACEUTICAL INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dryodine™ Antibacterial Gel is indicated for use in the management/cleaning of wet ulcers and wounds such as venous stasis ulcers, pressure sores, diabetic foot ulcers, and traumatic and surgical wounds. Dryodine™ Antibacterial Gel assists to keep lesions soft and pliable.
    Device Description
    Dryodine™ Antibacterial Gel consists of 0.1mm diameter biodegradable hydrophilic beads of cadexomer dispersed in a hydrophilic gel comprised of polyethylene glycol and poloxamer and contains 0.9% by weight iodine. The device is presented as a prescription product that requiring a physician to diagnosis the disease state and prescribe the product.
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    K Number
    K093051
    Device Name
    HYLATOPIC PLUS EMOLLIENT FOAM
    Manufacturer
    COLLEGIUM PHARMACEUTICAL INCORPORATED
    Date Cleared
    2009-12-07

    (68 days)

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

    COLLEGIUM PHARMACEUTICAL INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Under the supervision of a healthcare professional, Hylatopic™ Plus Emollient Foam, an aerosol-based emollient foam, is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Hylatopic™ Plus Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Hylatopic™ Plus Emollient Foam is indicated for use in: - Atopic Dermatitis - Allergic Contact Dermatitis - Radiation Dermatitis
    Device Description
    Hylatopic™ Plus Emollient Foam is a non-steroidal, non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When Hylatopic™ Plus Emollient Foam is dispensed, foam is formed. The propellant in the foam dissipates very quickly and the foam is then rubbed on the affected skin. The Hylatopic™ Plus Emollient Foam when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. This device is presented as a prescription product that requires the physician to diagnosis the disease state and prescribe the product.
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    K Number
    K083024
    Device Name
    HYLATOPIC EMOLLIENT FOAM
    Manufacturer
    COLLEGIUM PHARMACEUTICAL INCORPORATED
    Date Cleared
    2009-03-27

    (169 days)

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

    COLLEGIUM PHARMACEUTICAL INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Under the supervision of a healthcare professional, Hylatopic™ Emollient Foam, an aerosolbased emollient foam. is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Hylatopic™ Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Hylatopic TM Emollient Foam is indicated for use in: - · Atopic Dermatitis - Allergic Contact Dermatitis - Radiation Dermatitis .
    Device Description
    Hylatopic™ Emollient Foam is a non-steroidal, non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When Hylatopic™ Emollient Foam is dispensed, foam is formed. The propellant in the foam dissipates very quickly and the foam is then rubbed on the affected skin. The Hylatopic™ Emollient Foam when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. This device is presented as a prescription product that requires the physician to diagnosis of the disease state and prescribes the product.
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