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510(k) Data Aggregation

    K Number
    K153756
    Device Name
    Microlyte Ag
    Manufacturer
    IMBED BIOSCIENCES, INC.
    Date Cleared
    2016-08-04

    (218 days)

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

    IMBED BIOSCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Microlyte™ Ag wound dressing is indicated for the management of wounds and can be used over-thecounter for minor wounds such as abrasions and lacerations, minor cuts, and minor scalds and burns. Under the direction of a healthcare professional, Microlyte™ Ag may be used for more serious wounds such as partial and full thickness pressure ulcers, venous stasis ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds. Microlyte™ Ag wound dressing may be used over debrided and grafted partial thickness wounds.
    Device Description
    Microlyte™ Ag wound dressing is a sterile, single use unsupported synthetic absorbent polyvinyl alcohol hydrogel sheet with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.4 mg of silver in a 2 inch x 2 inch dressing, equivalent to 0.1 mg/sq. inch.
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