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

    TAMARI-KAPLITT

    K Number: K760695 · Decision Oct 6, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    161
    Applicant Total
    1
    Review Days
    16

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    Basic Information

    Device Name
    TAMARI-KAPLITT
    K Number
    K760695
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3535
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Yehuda Tamari
    Date Received
    September 20, 1976
    Decision Date
    October 6, 1976
    Product Code
    DSP
    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
    DSP System, Balloon, Intra-Aortic And Control

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