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

    INAMED RHEMO-D (TM) DILATOR

    K Number: K894618 · Decision Jan 18, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    4
    Applicant Total
    7
    Review Days
    182

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    Basic Information

    Device Name
    INAMED RHEMO-D (TM) DILATOR
    K Number
    K894618
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5450
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Inamed Development Co.
    Date Received
    July 20, 1989
    Decision Date
    January 18, 1990
    Product Code
    FFP
    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
    FFP Dilator, Rectal

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