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

    DUODERM HYDROACTIVE DRESSING

    K Number: K973689 · Decision Dec 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    4
    Review Days
    88

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    Basic Information

    Device Name
    DUODERM HYDROACTIVE DRESSING
    K Number
    K973689
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Convatec, Ltd.
    Date Received
    September 26, 1997
    Decision Date
    December 23, 1997
    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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