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510(k) Data Aggregation

    K Number
    K063069
    Device Name
    SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION
    Manufacturer
    MEDICAL MOLECULAR THERAPUETICS LLC
    Date Cleared
    2007-07-13

    (280 days)

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

    MEDICAL MOLECULAR THERAPUETICS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the Over-The-Counter Indications: For normal skin and minor wounds, ulcerations and burns, abraded skin, and irritated areas. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing action. For Professional Prescription Indications: To cleanse, moisten and irrigate skin and dermal lesions; Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations.
    Device Description
    A buffered skin and wound cleansing solution that is intended for the external cleansing of dermal wounds and skin. The mechanical action of the fluid moving across the skin or wound surface provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The product contains a surfactant (soap), cocamidopropyl betaine, to assist with the removal foreign material such as dirt and debris. After application the wound is rinsed with water or normal saline. The Silvaklenz Antibacterial Silver Skin & Wound Cleanser is clear, odorless and colorless. The product is available in 2 oz, 4 oz, 8 oz and 16 oz spray bottles.
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    K Number
    K063063
    Device Name
    SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION
    Manufacturer
    MEDICAL MOLECULAR THERAPUETICS LLC
    Date Cleared
    2007-07-03

    (270 days)

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

    MEDICAL MOLECULAR THERAPUETICS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Over-The-Counter Indications: For minor burns, abraded skin, irritated areas and minor wounds. Professional Prescription Indications: Wound moistening solution for dermal lesions such as Stage I-IV pressure ulcers, stasis ulcers, foot ulcers, diabetic ulcers, post surgical wounds, first and second degree burns, abrasions and skin irritations.
    Device Description
    A buffered ionic silver aqueous wet dressing for external wound management. The product provides a moist environment that aids the body in the healing process. The non-irritating components of Silvion Antibacterial Silver Skin & Wound Moisturizing Solution allow the product to be used on mucous membranes, the skin as well as acute and chronic wounds. The silver provides effective protection of the solution against microbial contamination. The Silvion Antibacterial Silver Skin & Wound Moisturizing Solution is clear, odorless and colorless. The product is available in 2 oz, 4 oz, 8 oz and 16 oz spray bottles.
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