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

    LUBRICANO STERILE GEL

    K Number: K081990 · Decision Dec 5, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    144

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    Basic Information

    Device Name
    LUBRICANO STERILE GEL
    K Number
    K081990
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Farco Pharma GmbH
    Date Received
    July 14, 2008
    Decision Date
    December 5, 2008
    Product Code
    FHX
    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
    FHX Jelly, Lubricating, For Transurethral Surgical Instrument

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    Other Clearances by Farco Pharma GmbH

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