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

    THERMAL OPTION

    K Number: K932790 · Decision Jan 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    45
    Applicant Total
    15
    Review Days
    233

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    Basic Information

    Device Name
    THERMAL OPTION
    K Number
    K932790
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cox Medical Ent., Inc.
    Date Received
    June 9, 1993
    Decision Date
    January 28, 1994
    Product Code
    KGE
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KGE Forceps, Biopsy, Electric

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