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

    OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138

    K Number: K992308 · Decision Sep 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    66

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    Basic Information

    Device Name
    OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138
    K Number
    K992308
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6100
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lifetek Medical, Inc.
    Date Received
    July 9, 1999
    Decision Date
    September 13, 1999
    Product Code
    MQE
    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
    MQE Needle, Assisted Reproduction

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    Other Clearances by Lifetek Medical, Inc.

    K Number Device Name
    K921518 LIFETEK IUI CATHETER