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

    MICROCYCLER

    K Number: K915166 · Decision Sep 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    9
    Applicant Total
    2
    Review Days
    1027

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    Basic Information

    Device Name
    MICROCYCLER
    K Number
    K915166
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Inventors Corp., Inc.
    Date Received
    November 15, 1991
    Decision Date
    September 7, 1994
    Product Code
    FCN
    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
    FCN Urinary Drainage Collection Kit, For Indwelling Catheter

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    Other Clearances by Medical Inventors Corp., Inc.

    K Number Device Name
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