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510(k) Data Aggregation

    K Number
    K180893
    Device Name
    IHM Technology Bandage
    Manufacturer
    Protege Biomedical
    Date Cleared
    2018-09-19

    (167 days)

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

    Protege Biomedical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IHM Bandage is intended for the management and external temporary control of bleeding from minor scrapes, minor abrasions and minor lacerations.
    Device Description
    IHM Technology Bandages are comprised of two primary components; IHM compound and gauze. IHM is a mineral based compound comprised of aluminum silicate and aluminum sulfate. The IHM compound is then coated on gauze or the gauze pad of an adhesive bandage. The combination creates a new type of bandage.
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