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

    EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT

    K Number: K951533 · Decision Jul 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    22
    Applicant Total
    26
    Review Days
    93

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    Basic Information

    Device Name
    EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT
    K Number
    K951533
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ballard Medical Products
    Date Received
    April 3, 1995
    Decision Date
    July 5, 1995
    Product Code
    KDH
    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
    KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

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