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

    TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING

    K Number: K051542 · Decision Mar 17, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    1
    Review Days
    280

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    Basic Information

    Device Name
    TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING
    K Number
    K051542
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Triosyn Corp.
    Date Received
    June 10, 2005
    Decision Date
    March 17, 2006
    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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