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

    BIO-CARB D16000, D16001, AND D17000

    K Number: K861646 · Decision Aug 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    99

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    Basic Information

    Device Name
    BIO-CARB D16000, D16001, AND D17000
    K Number
    K861646
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5830
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Societe D' Analyses Bio-Pharmaceutiques,Inc.
    Date Received
    April 30, 1986
    Decision Date
    August 7, 1986
    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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