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

    ECLIPSE HEART SUPPORT FOR CORONARY ARTER

    K Number: K843216 · Decision Sep 20, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    656
    Registration Numbers
    656
    Same Product Code
    99
    Applicant Total
    2
    Review Days
    36

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    Basic Information

    Device Name
    ECLIPSE HEART SUPPORT FOR CORONARY ARTER
    K Number
    K843216
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Biotrac Laboratories
    Date Received
    August 15, 1984
    Decision Date
    September 20, 1984
    Product Code
    GAD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAD Retractor

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