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

    HEMASITE ACCESSORIES MODIFICATION

    K Number: K840437 · Decision Feb 21, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    9
    Applicant Total
    35
    Review Days
    20

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    Basic Information

    Device Name
    HEMASITE ACCESSORIES MODIFICATION
    K Number
    K840437
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Renal Systems, Inc.
    Date Received
    February 1, 1984
    Decision Date
    February 21, 1984
    Product Code
    KNZ
    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
    KNZ Accessories, A-V Shunt

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    Other Clearances by Renal Systems, Inc.

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    K843963 DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD
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    K842258 RENATRON
    K841543 CONCENTRATE CONDUCTIVITY METER
    K840182 RENAPAK CONCENTRATE MIXING SYS.
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