LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K965120
    Device Name
    ALLCLENZ WOUND CLEANSER
    Manufacturer
    DPT LABORATORIES, LTD.
    Date Cleared
    1997-03-21

    (88 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    DPT LABORATORIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the cleansing of dermal lesions such as stage I-IV pressure uicers, stasis الداريع s, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritation of the skin.
    Device Description
    The Allclenz " Wound Cleanser is a colorless, transparent solution supplied nonsterile in 12 fl. oz. plastic bottles equipped with trigger-spray intended for cleansing and irrigation of dermal wounds. Biocompatibility of the product has been established by primary dermal irritation (rabbit), ocular irritation (rabbit), sensitization (guinea pig), and in vitro cytotoxicity studies.
    Ask a Question

    Page 1 of 1