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510(k) Data Aggregation

    K Number
    K171148
    Device Name
    Aleo BME Liquid Bandage
    Manufacturer
    Aleo BME Inc.
    Date Cleared
    2018-01-12

    (268 days)

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

    Aleo BME Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Over the counter: Aleo BME Liquid Bandage is intended to cover and protect the skin from outside dirt and microbial penetration in minor cuts, scrapes, burns, skin irritations and abrasions. Prescription Use: Aleo BME Liquid Bandage is intended to cover and protect the skin from outside dirt and microbial penetration for minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.
    Device Description
    ALEO liquid bandage is a tough elastic skin protectant for covering minor skin cuts, scrapes, abrasions and cracks. When applied, it rapidly forms water-proof, breathable and transparent protection that forms an effective barrier to prevent microbial penetration from the external environment while the polymeric film remains intact.
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