BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MENTOR(R) SUR-E-TROL(R)

    K Number: K910637 · Decision May 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    18
    Review Days
    89

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    Basic Information

    Device Name
    MENTOR(R) SUR-E-TROL(R)
    K Number
    K910637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Mentor O & O, Inc.
    Date Received
    February 13, 1991
    Decision Date
    May 13, 1991
    Product Code
    FRN
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRN Pump, Infusion

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