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    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    IM-9C MICROINJECTORS

    K Number: K001910 · Decision Jul 7, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    22
    Applicant Total
    20
    Review Days
    14

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    Basic Information

    Device Name
    IM-9C MICROINJECTORS
    K Number
    K001910
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6150
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Narishige Co., Ltd.
    Date Received
    June 23, 2000
    Decision Date
    July 7, 2000
    Product Code
    MQJ
    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
    MQJ Micromanipulators And Microinjectors, Assisted Reproduction

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    K003302 IM-5A INJECTOR
    K003303 IM-5B MICROINJECTOR
    K003300 MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
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