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

    BARIUM SULFATE, USP IN SUSPENSION

    K Number: K800459 · Decision May 30, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    91

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    Basic Information

    Device Name
    BARIUM SULFATE, USP IN SUSPENSION
    K Number
    K800459
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Central Pharmaceuticals, Inc.
    Date Received
    February 29, 1980
    Decision Date
    May 30, 1980
    Product Code
    KTA
    Advisory Committee
    Unknown
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KTA Medium, Contrast, Radiologic

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