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510(k) Data Aggregation

    K Number
    K123678
    Device Name
    HYALMIX CREAM
    Manufacturer
    IGI LABORATORIES, INC.
    Date Cleared
    2013-12-16

    (381 days)

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

    IGI LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Under the supervision of a healthcare professional, Hylamix Cream 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. Hylamix Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Hylamix Cream is indicated for use in: Atopic Dermatitis Allergic Contact Dermatitis Radiation Dermatitis
    Device Description
    Non-sterile, white, fragrance free, topical cream. Hylamix forms a physical barrier which maintains a moist wound and skin environment, and will be marketed in a 100 g tube, and 450 g jar as a prescription device.
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    K Number
    K123724
    Device Name
    DERMISEB CREAM
    Manufacturer
    IGI LABORATORIES, INC.
    Date Cleared
    2013-08-28

    (267 days)

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

    IGI LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Under the supervision of a healthcare professional, Dermiseb Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Dermiseb Cream also aids to relieve dry, waxy skin by maintaining a moist wound and skin environment. A moist wound and skin environment is beneficial to the healing process. Dermiseb Cream in indicated for use in: - Seborrhea - Seborrheic Dermatitis
    Device Description
    Non-sterile, off-white to slight pale-yellow colored, low odor, steroid-free, fragrance free, topical cream. Dermiseb Cream forms a physical barrier to relieve dry waxy skin by maintaining a moist wound and skin environment, and will be marketed in a 30 g tube as a prescription device.
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