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

    NG SECURE

    K Number: K953375 · Decision Sep 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    3
    Review Days
    52

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    Basic Information

    Device Name
    NG SECURE
    K Number
    K953375
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    M.C. Johnson Co., Inc.
    Date Received
    July 18, 1995
    Decision Date
    September 8, 1995
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by M.C. Johnson Co., Inc.

    K Number Device Name
    K872525 A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSITIONING MECH
    K832702 POCKET AID