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510(k) Data Aggregation

    K Number
    K113312
    Device Name
    HY-CHLO(TM)WOUND SCRUB
    Manufacturer
    PATRIN PHARMA
    Date Cleared
    2012-08-21

    (286 days)

    Product Code
    FQH, FOH
    Regulation Number
    880.5475
    Why did this record match?
    Applicant Name (Manufacturer) :

    PATRIN PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTC: Hy-Chlo™ Wound Solution is intended for removal of foreign objects such as dirt, for cleansing of minor cuts, lacerations, abrasions and wounds. Professional Use: Hy-Chlo™ Wound Solution is intended to be used under the supervision of healthcare professional in the cleansing of acute, chronic and/or open wounds such as Stage I-IV pressure ulcers, diabetic foot and leg ulcers, surgical wounds, first and second degree burns and grafted and donor sites.
    Device Description
    Hy-Chlo™ Wound Solution is an aqueous, clear, colorless solution that cleans open wounds. The solution delivers sodium hypochlorite as a preservative with sodium bicarbonate as a pH modifier. Hy-Chlo™ Wound Solution will be supplied in heat sealed, impervious, mold extruded HDPE bottles. A permanent affixed label will be on each bottle.
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