BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201

    K Number: K000950 · Decision May 12, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    50
    Applicant Total
    3
    Review Days
    50

    Basic Information

    Device Name
    EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
    K Number
    K000950
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6110
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    LABOTECT LABOR-TECHNIK GOTTINGEN
    Date Received
    March 23, 2000
    Decision Date
    May 12, 2000
    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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    Other Clearances by LABOTECT LABOR-TECHNIK GOTTINGEN

    K Number Device Name
    K021438 INSEMINATION CATHETER, MODEL 320301
    K003056 OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218