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

    SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK)

    K Number: K895454 · Decision Nov 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    50
    Applicant Total
    32
    Review Days
    70

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    Basic Information

    Device Name
    SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK)
    K Number
    K895454
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1390
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Advance Medical Designs, Inc.
    Date Received
    September 5, 1989
    Decision Date
    November 14, 1989
    Product Code
    DRC
    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
    DRC Trocar

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