BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    CLICKFINE PEN NEEDLE

    K Number: K100436 · Decision Apr 30, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    466
    Registration Numbers
    466
    Same Product Code
    680
    Applicant Total
    10
    Review Days
    73

    Basic Information

    Device Name
    CLICKFINE PEN NEEDLE
    K Number
    K100436
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    YPSOMED AG
    Date Received
    February 16, 2010
    Decision Date
    April 30, 2010
    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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