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

    GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY

    K Number: K850285 · Decision Feb 28, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    9
    Review Days
    36

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    Basic Information

    Device Name
    GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY
    K Number
    K850285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Premium Plastics, Inc.
    Date Received
    January 23, 1985
    Decision Date
    February 28, 1985
    Product Code
    KOD
    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
    KOD Catheter, Urological

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    K890107 GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT
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