BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GASTRIC LAVAGE KIT-DISPOSABLE

    K Number: K791400 · Decision Aug 16, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    7
    Applicant Total
    8
    Review Days
    31

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    Basic Information

    Device Name
    GASTRIC LAVAGE KIT-DISPOSABLE
    K Number
    K791400
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Acumed Instruments Corp.
    Date Received
    July 16, 1979
    Decision Date
    August 16, 1979
    Product Code
    GBQ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GBQ Catheter, Continuous Irrigation

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