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

    MICROMANIPULATOR

    K Number: K003142 · Decision Nov 22, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    22
    Applicant Total
    7
    Review Days
    43

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    Basic Information

    Device Name
    MICROMANIPULATOR
    K Number
    K003142
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6150
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Research Instruments , Ltd.
    Date Received
    October 10, 2000
    Decision Date
    November 22, 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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