BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit

    K Number: K152682 · Decision May 5, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    2
    Review Days
    230

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    Basic Information

    Device Name
    Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit
    K Number
    K152682
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.6180
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Willian A. Cook Australia Pty, Ltd.
    Date Received
    September 18, 2015
    Decision Date
    May 5, 2016
    Product Code
    MQL
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQL Media, Reproductive

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