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

    L.T.C. 1000 URINARY DRAINAGE BAG

    K Number: K895957 · Decision Oct 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    5
    Review Days
    13

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    Basic Information

    Device Name
    L.T.C. 1000 URINARY DRAINAGE BAG
    K Number
    K895957
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Medical Marketing, Inc.
    Date Received
    October 11, 1989
    Decision Date
    October 24, 1989
    Product Code
    KNX
    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
    KNX Collector, Urine, (And Accessories) For Indwelling Catheter

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    Other Clearances by Intl. Medical Marketing, Inc.

    K Number Device Name
    K897181 L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
    K895824 L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET
    K896621 L.T.C. REPLACEMENT GASTROSTOMY TUBE
    K895616 L.T.C. FEEDING TUBE