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

    COOPER LASER SONICS CUSA MODEL 200

    K Number: K853143 · Decision Oct 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    6
    Applicant Total
    54
    Review Days
    79

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    Basic Information

    Device Name
    COOPER LASER SONICS CUSA MODEL 200
    K Number
    K853143
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Cooper Lasersonics, Inc.
    Date Received
    July 29, 1985
    Decision Date
    October 16, 1985
    Product Code
    LBK
    Advisory Committee
    Unknown
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LBK Neurosurgical Ultrasonic Instruments

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