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

    TOP FINE

    K Number: K063466 · Decision Mar 2, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    466
    Registration Numbers
    466
    Same Product Code
    680
    Applicant Total
    2
    Review Days
    106

    Basic Information

    Device Name
    TOP FINE
    K Number
    K063466
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DAEJIN TECH MEDICAL MANUFACTURING CO., LTD.
    Date Received
    November 16, 2006
    Decision Date
    March 2, 2007
    Product Code
    FMI
    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
    FMI Needle, Hypodermic, Single Lumen

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