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

    NASOGASTRIC TUBE HOLDER, MODEL 160

    K Number: K994300 · Decision Feb 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    13
    Review Days
    51

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    Basic Information

    Device Name
    NASOGASTRIC TUBE HOLDER, MODEL 160
    K Number
    K994300
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dale Medical Products, Inc.
    Date Received
    December 21, 1999
    Decision Date
    February 10, 2000
    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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