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

    HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME

    K Number: K971687 · Decision Jul 29, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    76
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME
    K Number
    K971687
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    National Medical Care, Inc.
    Date Received
    May 2, 1997
    Decision Date
    July 29, 1997
    Product Code
    FJK
    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
    FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

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    Other Clearances by National Medical Care, Inc.

    K Number Device Name
    K971313 NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET