BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    LAPARO-TENSER

    K Number: K970712 · Decision Jul 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    1
    Review Days
    510

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    Basic Information

    Device Name
    LAPARO-TENSER
    K Number
    K970712
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    L & T S.N.C. DI E. Lucini & C.
    Date Received
    February 26, 1997
    Decision Date
    July 21, 1998
    Product Code
    HET
    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
    HET Laparoscope, Gynecologic (And Accessories)

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