BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    TurboSEAL Nasogastric Aspiration Tube

    K Number: K142483 · Decision Dec 19, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    106

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    Basic Information

    Device Name
    TurboSEAL Nasogastric Aspiration Tube
    K Number
    K142483
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Turboseal, L.P.
    Date Received
    September 4, 2014
    Decision Date
    December 19, 2014
    Product Code
    BSS
    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
    BSS Tube, Nasogastric

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