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510(k) Data Aggregation

    K Number
    K150676
    Device Name
    L-Mesitran Dressing Family II- Soft and Tulle
    Manufacturer
    Theo Manufacturing BV
    Date Cleared
    2015-12-23

    (282 days)

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

    Theo Manufacturing BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    a) Over-The-Counter (OTC) use The L-Mesitran Dressing Family II - Soft and Tulle provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. For over the counter use, L-Mesitran Dressing Family II may be used for: - minor abrasions - lacerations - minor cuts - minor scalds and burns b) Prescription (Rx) use Under the supervision of a healthcare professional, The L-Mesitran Dressing Family II - Soft and Tulle provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. The L-Mesitran Dressing Family II is intended for the management of the following: - Diabetic foot ulcers - Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) - Pressure ulcers / sores (partial and full thickness) - 1st and 2nd degree partial thickness burns - Donor sites, and traumatic and surgical wounds L-Mesitran Soft and Tulle are to be used in conjunction with other secondary dressings.
    Device Description
    L-Mesitran® Soft and Tulle are wound dressings for the use on wounds • L-Mesitran® Soft is a gel that contains: 40% medical grade honey, medical grade hypoallergenic lanolin, propylene glycol, PEG 4000, and vitamins C and E. • L-Mesitran® Tulle is a non-adherent polyethylene dressing impregnated with the patented L-Mesitran® Soft gel.
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    K Number
    K053613
    Device Name
    L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE
    Manufacturer
    THEO MANUFACTURING BV
    Date Cleared
    2007-07-25

    (575 days)

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

    THEO MANUFACTURING BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    L-Mesitran Hydro and Border dressings are indicated for acute and chronic superficial wounds such as: bruises, cuts, bedsores, first and second-degree burns and other traumatic wounds, venous and arterial ulcera, diabetes ulcers, donor sites, and post-operative wounds. L-Mesitran Hydro and Border should not be used as a covering for deep narrow cavities, dirty wounds (these should first be cleansed), third-degree burns and fistulae. Maintains a moist wound healing environment. This moist environment supports optimal wound healing. L-Mesitran Active dressings are indicated for treating minor burns, superficial cuts, lacerations and abrasions, and other small wounds. Maintains a moist wound healing environment. This moist environment supports optimal wound healing. L-Mesitran dressings are indicated for acute and chronic superficial wounds such as: bruises, tears, pressure ulcers, venous and arterial ulcera, diabetes ulcers, donor sites, cuts, first and second degree burns, postoperative wounds and other external wounds caused by trauma. L-Mesitran Net is to be used in conjunction with other secondary dressings. It should not be used on its own as a covering for dirty infected and heavily exudating wounds (should first be cleansed), third degree burns, or deep narrow cavities. Maintains a moist wound healing environment. This moist environment supports optimal wound healing.
    Device Description
    L-Mesitran Hydro, L-Mesitran Border, and L-Mesitran Active are hydro-active hydrogel wound dressings containing honey. L-Mesitran Net is a hydro-active hydrogel coated wound dressing containing honey on an open weave polyester net.
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