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510(k) Data Aggregation

    K Number
    K023969
    Device Name
    REACTIVE SKIN DECONTAMINATION LOTION
    Manufacturer
    Date Cleared
    2003-03-25

    (116 days)

    Product Code
    Regulation Number
    878.4014
    Why did this record match?
    Product Code :

    MAC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Reactive Skin Decontamination Lotion is intended to remove or neutralize chemical warfare agents and T-2 toxin from the skin.
    Device Description
    The RSDL lotion is pre-impregnated in a 2 x 3.9 x 0.4 inch, or 3.9 x 3.9 x 0.4 inch foam sponge applicator pad. Each applicator pad is packaged as a single unit in a heat-sealed polyethylene-lined aluminum foil pouch. The foil pouch is covered by a kraft paper outer layer to facilitate coloring of the finished package and to make opening the package possible when wearing CW protective clothing.
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