BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020

    K Number: K022112 · Decision Apr 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    243
    Same Product Code
    648
    Applicant Total
    6
    Review Days
    279

    Basic Information

    Device Name
    FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
    K Number
    K022112
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    FORTUNE MEDICAL INSTRUMENT CORP.
    Date Received
    June 28, 2002
    Decision Date
    April 3, 2003
    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 FORTUNE MEDICAL INSTRUMENT CORP.

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