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

    I.V. BAG ADDISEAL

    K Number: K832247 · Decision Jul 26, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    116
    Applicant Total
    16
    Review Days
    15

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    Basic Information

    Device Name
    I.V. BAG ADDISEAL
    K Number
    K832247
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5025
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Baxa Corp., Sub. of Cook Group, Inc.
    Date Received
    July 11, 1983
    Decision Date
    July 26, 1983
    Product Code
    KPE
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPE Container, I.V.

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