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

    RELIZORB

    K Number: DEN150001 · Decision Nov 20, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    322

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    Basic Information

    Device Name
    RELIZORB
    K Number
    DEN150001
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    876.5985
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Alcresta, Inc.
    Date Received
    January 2, 2015
    Decision Date
    November 20, 2015
    Product Code
    PLQ
    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
    PLQ Enzyme Packed Cartridge

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