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

    KF-101-10 DIALYZER

    K Number: K822338 · Decision Feb 16, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    69
    Review Days
    196

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    Basic Information

    Device Name
    KF-101-10 DIALYZER
    K Number
    K822338
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Extracorporeal Medical Specialities, Inc.
    Date Received
    August 4, 1982
    Decision Date
    February 16, 1983
    Product Code
    KOC
    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
    KOC Accessories, Blood Circuit, Hemodialysis

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    Other Clearances by Extracorporeal Medical Specialities, Inc.

    K Number Device Name
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    K833477 INTERSEPT 40 MICRON FILTER
    K833476 INTERSEPT 40 MICRON FILTER W/TUBING
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