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510(k) Data Aggregation

    K Number
    K160095
    Device Name
    Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz
    Manufacturer
    Simple Science, LLC
    Date Cleared
    2016-06-10

    (143 days)

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

    Simple Science, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Over-the-Counter Use: For management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, minor burns and intact skin. Prescription Use: For management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post-surgical wounds, first-and seconddegree burns, grafted and donor sites, and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.
    Device Description
    Simple Science Antimicrobial Wound & Skin Cleanser is a clear hypotonic solution topically applied to skin and wound areas. The subject device is a wound management and cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings (e.g. gauze). The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. Simple Science Antimicrobial Wound & Skin Cleanser contains the following ingredients: Ionized water (99.927%), Sodium chloride (0.06%), Hypochlorous acid (0.011%) and hypochlorite Ion (0.002%). Simple Science Antimicrobial Wound & Skin will be supplied in Polyethylene terephthalate (PET) bottles of various volumes (2 oz, 8 oz, 16 oz, 23 oz) with spray inserts / caps.
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    K Number
    K142592
    Device Name
    CleanSmart Wound Cleanser
    Manufacturer
    SIMPLE SCIENCE, LLC
    Date Cleared
    2015-09-02

    (352 days)

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

    SIMPLE SCIENCE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Over-the-Counter Use: For management of minor skin abrasions, minor irritations, minor cuts, minor cuts, minor burns and intact skin. Prescription Use: For management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post-surgical wounds, first-and second-degree burns, grafted and donor sites, and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.
    Device Description
    CleanSmart™ Wound Cleanser is a clear hypotonic solution topically applied to skin and wound areas. The subject device is a wound management and cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings (e.g. gauze). The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. CleanSmart™ Wound Cleanser contains the following ingredients: Ionized water (99.927%), Sodium chloride (0.06%), Hypochlorous acid (0.011%) and hypochlorite Ion (0.002%). CleanSmart™ Wound Cleanser will be supplied in Polyethylene terephthalate (PET) bottles of various volumes (2 oz, 8 oz, 16 oz, 23 oz) with spray inserts / caps.
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