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

    WAREXIN RECOMMENDED ALTERNATIVE DIALYZ

    K Number: K843520 · Decision Oct 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    56
    Applicant Total
    7
    Review Days
    27

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    Basic Information

    Device Name
    WAREXIN RECOMMENDED ALTERNATIVE DIALYZ
    K Number
    K843520
    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
    September 7, 1984
    Decision Date
    October 4, 1984
    Product Code
    LIF
    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
    LIF Dialyzer Reprocessing System

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    Other Clearances by Mesa Medical, Inc.

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    K834447 ECHO MM1000
    K821383 ECHO, MODEL MM-1000