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

    CONTROL III ELITE

    K Number: K992661 · Decision Sep 14, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    72
    Applicant Total
    2
    Review Days
    36

    Basic Information

    Device Name
    CONTROL III ELITE
    K Number
    K992661
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6890
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MARIL PRODUCTS, INC.
    Date Received
    August 9, 1999
    Decision Date
    September 14, 1999
    Product Code
    LRJ
    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
    LRJ Disinfectant, Medical Devices

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