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510(k) Data Aggregation

    K Number
    K113772
    Device Name
    HPR EMOLLIENT FOAM
    Date Cleared
    2012-02-09

    (49 days)

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

    PRUGEN IP HOLDINGS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HPR™ Emollient Foam is indicated to manage and relieve the burning, itching and pain associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis. HPRTM Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
    Device Description
    HPR 114 Emollient Foam is a non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When HPR™ 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 HPR™ 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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    K Number
    K113774
    Device Name
    HPR PLUS EMOLLIENT FOAM
    Date Cleared
    2012-02-09

    (49 days)

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

    PRUGEN IP HOLDINGS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HPRTM Plus Emollient Foam is indicated to manage and relieve the burning, itching and pain associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis. HPRTM Plus Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
    Device Description
    HPR 114 Plus Emollient Foam is a non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When HPRTM 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 HPR " 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 of the disease state and prescribes the product.
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    K Number
    K110732
    Device Name
    EMULSION SB
    Date Cleared
    2011-06-03

    (79 days)

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

    PRUGEN IP HOLDINGS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Emulsion SBTM is intended to be used as a topical skin care preparation applied at least twice daily to affected areas of the skin to improve dry skin conditions and to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis and other dry skin conditions, by maintaining a moist wound and skin environment.
    Device Description
    Emulsion SB 100 is a non-sterile, viscous, lipid rich emulsion intended for topical application. It is presented for prescription (requiring a physician diagnosis disease state) use in a 90 gm tube.
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    K Number
    K093156
    Device Name
    PRUCLAIR NONSTEROIDAL CREAM
    Date Cleared
    2010-06-24

    (261 days)

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

    PRUGEN IP HOLDINGS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Under the supervision of a healthcare professional, PruClair™ non-steroidal cream is indicated to manage various types of dermatoses. PruClair™ non-steroidal cream is indicated for minor burns, minor lacerations, and minor irritations.
    Device Description
    PruClair™ non-steroidal cream is a non-sterile, viscous emulsion/formulation, which is presented for both Prescription (requiring a physician diagnosis disease state) and over-the-counter (OTC) use.
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    K Number
    K093159
    Device Name
    PR CREAM
    Date Cleared
    2010-06-24

    (261 days)

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

    PRUGEN IP HOLDINGS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PR™ cream is indicated to manage various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. PR™ cream helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
    Device Description
    PR™ cream is a non-sterile cream formulation intended for topical use only. It is presented for Prescription (requiring a physician diagnosis disease state) use. PRTM cream is or topical dermatologic use only. PR™ cream is applied in a thin layer to affected areas 2-3 times per day or as directed by a physician. PRTM cream is a nonsteroidal cream comprised of aluminum magnesium hydroxide stearate, cetyl dimethicone copolyol, cyclomethicone, hexyl laurate, polyglyceryl-4-isostearate, prified water, and sodium chloride. Contains phenoxyethanol and propylparaben as preservatives.
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    K Number
    K092878
    Device Name
    PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE
    Date Cleared
    2010-01-15

    (119 days)

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

    PRUGEN IP HOLDINGS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PruTect™ is a water-based emulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, Ist and 2nd degree burns, including sunburns, and radiation dermatis. When applied properly to a wound, PruTect™ provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination. PruTectTM 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 Abrasio»
    Device Description
    PruTect™ Topical Emulsion is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requiring a physician diagnosis disease state) use in both 45 gm and 90 gm tube formats.
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