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

    T SERIES VESSEL TIPS

    K Number: K893438 · Decision Jun 8, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    36
    Review Days
    36

    Basic Information

    Device Name
    T SERIES VESSEL TIPS
    K Number
    K893438
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    AKCESS MEDICAL PRODUCTS, INC.
    Date Received
    May 3, 1989
    Decision Date
    June 8, 1989
    Product Code
    FKW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FKW Tip, Vessel

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