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

    LUOFUCON Collagen Wound Dressing

    K Number: K213598 · Decision Sep 20, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    122
    Registration Numbers
    122
    Same Product Code
    155
    Applicant Total
    2
    Review Days
    309

    Basic Information

    Device Name
    LUOFUCON Collagen Wound Dressing
    K Number
    K213598
    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
    November 15, 2021
    Decision Date
    September 20, 2022
    Product Code
    KGN
    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
    KGN Wound Dressing With Animal-Derived Material(S)

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    Other Clearances by Huizhou Foryou Medical Devices CO., Ltd.

    K Number Device Name
    K211123 LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel