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

    Clickfine Pen Needle, Penfine Classic Pen Needle

    K Number: K171984 · Decision Oct 11, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    12
    Review Days
    103

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    Basic Information

    Device Name
    Clickfine Pen Needle, Penfine Classic Pen Needle
    K Number
    K171984
    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
    June 30, 2017
    Decision Date
    October 11, 2017
    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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