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

    RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT

    K Number: K852749 · Decision Sep 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    60
    Applicant Total
    7
    Review Days
    75

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    Basic Information

    Device Name
    RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT
    K Number
    K852749
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Mesa Medical, Inc.
    Date Received
    June 27, 1985
    Decision Date
    September 10, 1985
    Product Code
    FKQ
    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
    FKQ System, Dialysate Delivery, Central Multiple Patient

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