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

    MODIFICATION TO ACTICOAT FOAM DRESSING

    K Number: K010447 · Decision Mar 15, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    MODIFICATION TO ACTICOAT FOAM DRESSING
    K Number
    K010447
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Westaim Biomedical, Inc.
    Date Received
    February 13, 2001
    Decision Date
    March 15, 2001
    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
    K002466 ACTICOAT COMPOSITE DRESSING
    K001519 ACTICOAT 7 DRESSING
    K992221 ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
    K000051 ACTICOAT FOAM DRESSING
    K983833 ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE