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

    STRAIGHT-LINES I.V. ORGANIZER

    K Number: K920965 · Decision Apr 7, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    401

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    Basic Information

    Device Name
    STRAIGHT-LINES I.V. ORGANIZER
    K Number
    K920965
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6500
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Taylor Bio-Medical, Inc.
    Date Received
    March 2, 1992
    Decision Date
    April 7, 1993
    Product Code
    FRA
    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
    FRA Purifier, Air, Ultraviolet, Medical

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