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510(k) Data Aggregation

    K Number
    K121134
    Device Name
    TL TRISEB CREAM
    Manufacturer
    TRIGEN LABORATORIES, INC.
    Date Cleared
    2012-07-25

    (103 days)

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

    TRIGEN LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Under the supervision of a healthcare professional, TL Triseb Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. TL Triseb Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
    Device Description
    TL Triseb cream is a non-sterile viscous emulsion/cream formulation. TL Triseb Cream is an off-white, steroid-free, fragrance-free, water-based emulsion.
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    K Number
    K110762
    Device Name
    AVO BARRIER TOPICAL EMULSION
    Manufacturer
    TRIGEN LABORATORIES, INC.
    Date Cleared
    2011-11-18

    (245 days)

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

    TRIGEN LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AVO Cream Topical Emulsion is indicated for use in: - Full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers ● - Superficial wounds - 1st and 2nd degree burns, including sunburns . - Dermal donor and graft site management . - Radiation dermatitis . - Minor abrasions .
    Device Description
    AVO Cream Topical Emulsion is a water-based emulsion formulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation dermatitis. When applied properly to a wound, AVO Cream Topical Emulsion provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination.
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    K Number
    K110757
    Device Name
    TL-CERMIDE SKIN BARRIER EMULSION
    Manufacturer
    TRIGEN LABORATORIES, INC.
    Date Cleared
    2011-08-19

    (154 days)

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

    TRIGEN LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TL-Cermide Skin Emulsion is to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis. TL-Cermide Skin Emulsion helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
    Device Description
    TL-Cermide Skin Emulsion is a steroid-free, fragrance-free, ceramide-dominant formulation
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