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

    WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N

    K Number: K990348 · Decision Jul 26, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    52
    Applicant Total
    41
    Review Days
    171

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    Basic Information

    Device Name
    WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N
    K Number
    K990348
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6110
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CooperSurgical, Inc.
    Date Received
    February 5, 1999
    Decision Date
    July 26, 1999
    Product Code
    MQF
    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
    MQF Catheter, Assisted Reproduction

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