BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇬🇧 United Kingdom

    Silicone PHMB Foam Wound Dressing

    K Number: K190819 · Decision Jul 25, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    11
    Review Days
    115

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    Basic Information

    Device Name
    Silicone PHMB Foam Wound Dressing
    K Number
    K190819
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Medical Solutions, Ltd.
    Date Received
    April 1, 2019
    Decision Date
    July 25, 2019
    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 Advanced Medical Solutions, Ltd.

    K Number Device Name
    K213473 Antimicrobial Gelling Fiber Dressing with PHMB
    K210974 High Performance Antimicrobial Gelling Fiber with Silver
    K183645 Silver High Performance Dressing
    K180634 Surgical Silver Post Operative Dressing
    K181197 PHMB Foam Wound Dressing
    K163062 PHMB Antimicrobial Foam Wound Dressing
    K032742 SILVER FOAM WOUND DRESSING
    K041316 ANTIMICROBIAL ALGINATE DRESSING
    K024298 ANTIMICROBIAL ALGINATE DRESSING
    K010245 ACTIVHEAL SCAR MANAGEMENT DRESSING
    Search all 11 clearances from Advanced Medical Solutions, Ltd. →