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510(k) Data Aggregation

    K Number
    K200821
    Device Name
    anti-bacterial bandage
    Manufacturer
    Planet (Suzhou) Medical Products Co., Ltd
    Date Cleared
    2020-10-19

    (203 days)

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

    Planet (Suzhou) Medical Products Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts,minor scrapes.
    Device Description
    Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts,minor scrapes. Anti-bacterial bandage is made of Fabric tape/polyethylene tape, and absorbent pad. Absorbent pad contains 0.1%/0.8% benzalkonium chloride. The Anti-bacterial bandage is EO sterilized, and is for single use only. Product shelf- life time: Three years
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