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

    MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.

    K Number: K873887 · Decision Dec 9, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    2
    Review Days
    77

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    Basic Information

    Device Name
    MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.
    K Number
    K873887
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    W.R. Grace & Co.-Conn.
    Date Received
    September 23, 1987
    Decision Date
    December 9, 1987
    Product Code
    KDI
    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
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

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    Other Clearances by W.R. Grace & Co.-Conn.

    K Number Device Name
    K860804 MEDICAL ADHESIVE TAPE