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

    EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip

    K Number: K161275 · Decision Jan 23, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    262

    Basic Information

    Device Name
    EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip
    K Number
    K161275
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6130
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    RESEARCH INSTRUMENTS LIMITED
    Date Received
    May 6, 2016
    Decision Date
    January 23, 2017
    Product Code
    MQH
    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
    MQH Microtools, Assisted Reproduction (Pipettes)

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