BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE

    K Number: K983833 · Decision Dec 10, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    6
    Review Days
    41

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    Basic Information

    Device Name
    ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE
    K Number
    K983833
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Westaim Biomedical, Inc.
    Date Received
    October 30, 1998
    Decision Date
    December 10, 1998
    Product Code
    KMF
    Advisory Committee
    General Hospital
    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
    KMF Bandage, Liquid

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    Other Clearances by Westaim Biomedical, Inc.

    K Number Device Name
    K010447 MODIFICATION TO ACTICOAT FOAM DRESSING
    K002466 ACTICOAT COMPOSITE DRESSING
    K001519 ACTICOAT 7 DRESSING
    K992221 ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
    K000051 ACTICOAT FOAM DRESSING