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

    LUOFUCON® Silver Collagen Dressing

    K Number: K240809 · Decision Dec 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    402
    Registration Numbers
    403
    Same Product Code
    861
    Applicant Total
    11
    Review Days
    266

    Basic Information

    Device Name
    LUOFUCON® Silver Collagen Dressing
    K Number
    K240809
    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
    March 25, 2024
    Decision Date
    December 16, 2024
    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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    Other Clearances by Huizhou Foryou Medical Devices Co., Ltd.

    K Number Device Name
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    K240485 LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)
    K232796 LUOFUCON® Collagen Particles (Collagen Wound Dressing)
    K223360 LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing
    K221110 LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing
    K223359 LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing
    K210718 LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing
    K201016 LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)
    K172554 LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing
    K173196 SUNTOUCH Dental Dressing
    Search all 11 clearances from Huizhou Foryou Medical Devices Co., Ltd. →