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

    CF 1211 CAPILLARY FLOW DIALYZER CODE

    K Number: K822395 · Decision Aug 12, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    206
    Review Days
    1

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    Basic Information

    Device Name
    CF 1211 CAPILLARY FLOW DIALYZER CODE
    K Number
    K822395
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5830
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Travenol Laboratories, S.A.
    Date Received
    August 11, 1982
    Decision Date
    August 12, 1982
    Product Code
    FJH
    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
    FJH Dialyzer, Disposable

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