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

    DEXTRANOMER

    K Number: K872117 · Decision Jul 24, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    53

    Basic Information

    Device Name
    DEXTRANOMER
    K Number
    K872117
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4018
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    INTERWORLD, INC.
    Date Received
    June 1, 1987
    Decision Date
    July 24, 1987
    Product Code
    KOZ
    Advisory Committee
    General, Plastic Surgery
    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
    KOZ Beads, Hydrophilic, For Wound Exudate Absorption

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