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

    SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION

    K Number: K914329 · Decision Apr 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    188

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    Basic Information

    Device Name
    SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION
    K Number
    K914329
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4120
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ellman Intl. Mfg., Inc.
    Date Received
    September 27, 1991
    Decision Date
    April 2, 1992
    Product Code
    HGI
    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
    HGI Electrocautery, Gynecologic (And Accessories)

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    Other Clearances by Ellman Intl. Mfg., Inc.

    K Number Device Name
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