BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AMIELLE

    K Number: K983045 · Decision Nov 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    3
    Applicant Total
    10
    Review Days
    85

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    Basic Information

    Device Name
    AMIELLE
    K Number
    K983045
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.3900
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Owen Mumford USA, Inc.
    Date Received
    September 1, 1998
    Decision Date
    November 25, 1998
    Product Code
    KXP
    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
    KXP Stent, Vaginal

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    Other Clearances by Owen Mumford USA, Inc.

    K Number Device Name
    K013362 AUTOJECT 2
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    K983994 UNIFINE
    K983974 OWEN MUMFORD 3ML AUTOPEN
    K982275 RAPPORT V.T.D.
    K973899 UNIFINE PENTIPS
    K971443 RAPPORT V.T.D.
    K953735 AUTOJECT MINI
    K945660 AUTOJECT 2