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510(k) Data Aggregation

    K Number
    K123910
    Device Name
    WOUNDWASH SALINE SPRAY
    Date Cleared
    2013-10-29

    (314 days)

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

    NEILMED PHARMACEUTICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To cleanse minor wounds and scrapes. The product is not to be used for body cavities, canals, eyes, or mouth.
    Device Description
    Dr. Mehta's Wound Wash Saline SprayTM consists of drug and preservative-free sterile isotonic saline solution that is delivered in atomized spray form by means of activating the actuator. Dr. Mehta's Wound Wash Saline SprayTM distributed as a single can includes 0.9% saline (sodium chloride) solution. The product utilizes bag-on-valve technology (bag in can). The propellant, compressed air, is charged into the container between bag and the can creating a means to dispense the contents of the bag, i.e., sterile isotonic salution. The product consists of specially designed actuator to deliver an effective consistent spray of the solution on the wound area. The filled device is sterilized by gamma radiation utilizing parameters those are validated according to ISO/AAMI 11137 requirements (Sterilization of health care products -Requirements for validation and routine control - Radiation sterilization). The product passes USP<71> Sterility Test. Dr. Mehta's Wound Wash Saline Spray™ is available as an over-thecounter product, and will be labeled with the following indication: "To cleanse minor wounds and scrapes.".
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