BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Unifine SafeControl

    K Number: K210399 · Decision Sep 17, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    466
    Registration Numbers
    466
    Same Product Code
    680
    Applicant Total
    9
    Review Days
    219

    Basic Information

    Device Name
    Unifine SafeControl
    K Number
    K210399
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Owen Mumford Ltd
    Date Received
    February 10, 2021
    Decision Date
    September 17, 2021
    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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