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

    SALINE, 1.3% W/O PRESERVATIVE

    K Number: K842723 · Decision Aug 3, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    16
    Applicant Total
    50
    Review Days
    21

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    Basic Information

    Device Name
    SALINE, 1.3% W/O PRESERVATIVE
    K Number
    K842723
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2875
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    E K Ind., Inc.
    Date Received
    July 13, 1984
    Decision Date
    August 3, 1984
    Product Code
    KIP
    Advisory Committee
    Hematology
    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
    KIP Formulations, Balanced Salt Solutions

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