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

    INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER

    K Number: K904265 · Decision Mar 6, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    7
    Applicant Total
    7
    Review Days
    169

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    Basic Information

    Device Name
    INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER
    K Number
    K904265
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Inamed Development Co.
    Date Received
    September 18, 1990
    Decision Date
    March 6, 1991
    Product Code
    FZW
    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
    FZW Expander, Surgical, Skin Graft

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