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

    NIR LAT MALE EXTERNAL CATHETER

    K Number: K855209 · Decision Jan 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    2
    Review Days
    11

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    Basic Information

    Device Name
    NIR LAT MALE EXTERNAL CATHETER
    K Number
    K855209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Mali, Inc.
    Date Received
    December 30, 1985
    Decision Date
    January 10, 1986
    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 Mali, Inc.

    K Number Device Name
    K864176 GENTLE FEEL