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

    UCEZ - STERILE LENS FOG REDUCTION DEVICE

    K Number: K905590 · Decision May 10, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    26
    Applicant Total
    6
    Review Days
    148

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    Basic Information

    Device Name
    UCEZ - STERILE LENS FOG REDUCTION DEVICE
    K Number
    K905590
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Inman Liebelt Corp.
    Date Received
    December 13, 1990
    Decision Date
    May 10, 1991
    Product Code
    OCT
    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
    OCT Anti Fog Solution And Accessories, Endoscopy

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