BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    WRENCH, GEXAGON, DRIVER

    K Number: K781179 · Decision Jul 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    107
    Review Days
    13

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    Basic Information

    Device Name
    WRENCH, GEXAGON, DRIVER
    K Number
    K781179
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.3730
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Telectronics, Inc.
    Date Received
    July 14, 1978
    Decision Date
    July 27, 1978
    Product Code
    DTF
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DTF Tools, Pacemaker Service

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