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

    Y2K2 ENTERNAL TUBE FLUID FILTER

    K Number: K051206 · Decision Nov 2, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    8
    Review Days
    175

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    Basic Information

    Device Name
    Y2K2 ENTERNAL TUBE FLUID FILTER
    K Number
    K051206
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Moss Medical Products
    Date Received
    May 11, 2005
    Decision Date
    November 2, 2005
    Product Code
    KNT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by Moss Medical Products

    K Number Device Name
    K030413 Y2K2 ENTERNAL FEEDING MANAGER
    K031492 MOSSMED DUAL INTERMITTENT ASPIRATOR
    K913701 MOSS - ANCHOR SET
    K910910 MOSS- ANCHOR SET
    K910912 MOSS NASAL TUBE MARK IV
    K910911 MOSS P.E.G. TRAY
    K910913 MOSS GASTROSTOMY TUBE