BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇦🇺 Australia

    AMNIGLOVE & AMNICOT

    K Number: K850758 · Decision Apr 15, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    5
    Applicant Total
    11
    Review Days
    49

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    Basic Information

    Device Name
    AMNIGLOVE & AMNICOT
    K Number
    K850758
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Go Medical Industries Pty. , Ltd.
    Date Received
    February 25, 1985
    Decision Date
    April 15, 1985
    Product Code
    HGE
    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
    HGE Amniotome

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