BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CONSED FECAL CONCENTRATION SYSTEM

    K Number: K884755 · Decision Jan 10, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    57

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    Basic Information

    Device Name
    CONSED FECAL CONCENTRATION SYSTEM
    K Number
    K884755
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.4010
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Applicant
    Donald L. Price, Ph.D.
    Date Received
    November 14, 1988
    Decision Date
    January 10, 1989
    Product Code
    IFP
    Advisory Committee
    Pathology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IFP Formalin, Neutral Buffered

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