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

    ILEX STOMA SEAL AND PROTECTIVE CREAM

    K Number: K780473 · Decision May 16, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    101
    Applicant Total
    1
    Review Days
    53

    Basic Information

    Device Name
    ILEX STOMA SEAL AND PROTECTIVE CREAM
    K Number
    K780473
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5900
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Virgil Pichierri
    Date Received
    March 24, 1978
    Decision Date
    May 16, 1978
    Product Code
    EXB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EXB Collector, Ostomy

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