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

    STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES

    K Number: K913223 · Decision Sep 4, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    30
    Review Days
    47

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    Basic Information

    Device Name
    STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES
    K Number
    K913223
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Device Inspection Co., Inc.
    Date Received
    July 19, 1991
    Decision Date
    September 4, 1991
    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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