BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇳 China

    LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel

    K Number: K211123 · Decision Apr 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    402
    Registration Numbers
    403
    Same Product Code
    861
    Applicant Total
    2
    Review Days
    372

    Basic Information

    Device Name
    LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
    K Number
    K211123
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Huizhou Foryou Medical Devices CO., Ltd.
    Date Received
    April 15, 2021
    Decision Date
    April 22, 2022
    Product Code
    FRO
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FRO Dressing, Wound, Drug

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