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

    COOL.CLICK 2

    K Number: K060819 · Decision Jun 16, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    81

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    Basic Information

    Device Name
    COOL.CLICK 2
    K Number
    K060819
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5430
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical House Products Limited
    Date Received
    March 27, 2006
    Decision Date
    June 16, 2006
    Product Code
    KZE
    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
    KZE Injector, Fluid, Non-Electrically Powered

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    Other Clearances by Medical House Products Limited

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