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

    ACTICOAT PRIMARY ANTIMICROBIAL DRESSING

    K Number: K992221 · Decision Jun 7, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    6
    Review Days
    342

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    Basic Information

    Device Name
    ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
    K Number
    K992221
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Westaim Biomedical, Inc.
    Date Received
    July 1, 1999
    Decision Date
    June 7, 2000
    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 Westaim Biomedical, Inc.

    K Number Device Name
    K010447 MODIFICATION TO ACTICOAT FOAM DRESSING
    K002466 ACTICOAT COMPOSITE DRESSING
    K001519 ACTICOAT 7 DRESSING
    K000051 ACTICOAT FOAM DRESSING
    K983833 ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE