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

    SUCTION IRRIGATOR

    K Number: K003443 · Decision Feb 1, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    2
    Applicant Total
    14
    Review Days
    87

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    Basic Information

    Device Name
    SUCTION IRRIGATOR
    K Number
    K003443
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4370
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Applied Medical
    Date Received
    November 6, 2000
    Decision Date
    February 1, 2001
    Product Code
    FHF
    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
    FHF System, Evacuator, Fluid

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