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

    GASTRIC LAVAGE KIT

    K Number: K780471 · Decision Jun 2, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    27
    Review Days
    70

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    Basic Information

    Device Name
    GASTRIC LAVAGE KIT
    K Number
    K780471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5365
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Gaymar Industries, Inc.
    Date Received
    March 24, 1978
    Decision Date
    June 2, 1978
    Product Code
    FAT
    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
    FAT Bougie, Esophageal, And Gastrointestinal, Gastro-Urology

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