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

    LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)

    K Number: K201016 · Decision Jan 28, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    22
    Review Days
    286

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    Basic Information

    Device Name
    LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)
    K Number
    K201016
    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 17, 2020
    Decision Date
    January 28, 2021
    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
    K250642 LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
    K240809 LUOFUCON® Silver Collagen Dressing
    K242856 LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
    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
    K213598 LUOFUCON Collagen Wound Dressing
    K211123 LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
    Search all 22 clearances from Huizhou Foryou Medical Devices Co., Ltd. →