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

    TUBES, LUKENS, TOMAS

    K Number: K781234 · Decision Aug 10, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    47
    Applicant Total
    1
    Review Days
    22

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    Basic Information

    Device Name
    TUBES, LUKENS, TOMAS
    K Number
    K781234
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Ludwig Medical, Inc.
    Date Received
    July 19, 1978
    Decision Date
    August 10, 1978
    Product Code
    KDQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KDQ Bottle, Collection, Vacuum

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