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510(k) Data Aggregation

    K Number
    K170270
    Device Name
    Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline
    Manufacturer
    LS Scientific Inc. D.B.A. KSE Scientific
    Date Cleared
    2017-06-23

    (147 days)

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

    LS Scientific Inc. D.B.A. KSE Scientific

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTC: For moistening absorbent wound dressings and cleaning minor burns, superficial abrasions and minor irritations of the skins. Not for injection. Rx: For moistening absorbent wound dressings and for moistening, debriding and cleaning acute and chronic dermal lesions, such as stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation. Not for injection.
    Device Description
    Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline device is a wound and device cleansing solution that is intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile saline for irrigation and meets all of the associated requirements defined in the USP. The subject device is offered in various bottle and cup sizes.
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