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

    CATHETERS, DRAINAGE

    K Number: K771048 · Decision Jul 19, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    12
    Applicant Total
    28
    Review Days
    39

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    Basic Information

    Device Name
    CATHETERS, DRAINAGE
    K Number
    K771048
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Axiom Medical, Inc.
    Date Received
    June 10, 1977
    Decision Date
    July 19, 1977
    Product Code
    FEG
    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
    FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation

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