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

    MARKERS, STAINLESS STEEL

    K Number: K770802 · Decision Jun 27, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    62

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    Basic Information

    Device Name
    MARKERS, STAINLESS STEEL
    K Number
    K770802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4650
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Cardio-Surgical, Inc.
    Date Received
    April 26, 1977
    Decision Date
    June 27, 1977
    Product Code
    KPK
    Advisory Committee
    General, Plastic Surgery
    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
    KPK Marker, Ostia, Aorto-Saphenous Vein

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