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

    URETHRAL TRAY W/OUT CAHTETER, 7650

    K Number: K771104 · Decision Jun 24, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    58
    Applicant Total
    42
    Review Days
    4

    Basic Information

    Device Name
    URETHRAL TRAY W/OUT CAHTETER, 7650
    K Number
    K771104
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    CONCORD LABORATORIES, INC.
    Date Received
    June 20, 1977
    Decision Date
    June 24, 1977
    Product Code
    FCM
    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
    FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

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