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

    CATHETER IRRIGATION TRAYS, #3300, 3310 &

    K Number: K801783 · Decision Aug 13, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    14
    Applicant Total
    29
    Review Days
    16

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    Basic Information

    Device Name
    CATHETER IRRIGATION TRAYS, #3300, 3310 &
    K Number
    K801783
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    The Healthcare Group Laboratories, Inc.
    Date Received
    July 28, 1980
    Decision Date
    August 13, 1980
    Product Code
    EYN
    Advisory Committee
    Gastroenterology, Urology
    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
    EYN Tray, Irrigation, Sterile

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