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510(k) Data Aggregation

    K Number
    K021012
    Device Name
    LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
    Manufacturer
    QUALITY MEDICAL SOLUSIONS LLC
    Date Cleared
    2002-06-25

    (88 days)

    Product Code
    HDY
    Regulation Number
    884.4260
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUALITY MEDICAL SOLUSIONS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as Uterine curettage, Labor induction, IUD placement and removal, and Radium placement
    Device Description
    This single use device is a hygroscopic laminaria cervical dilator designed to dilate (stretch open) the cervical os by cervical insertion of a cylindrical and expansible material into the cervical canal, made from the root of a seaweed (laminaria digitata). Laminaria expands when it absorbs moisture. The ability to increase in size slowly (usually 6 to 24 hours) is of advantage in physiologically dilating a closed body orifice such as the cervical canal. When used improperly, it may cause the patient major discomfort or uterine complications Laminaria is available in 2, 3, 4, 5, 6, 7, 8 and 9 mm diameter sizes with a length varving between 50 and 65 mm. Each laminaria is drilled and attached to a 75-95 mm string to facilitate removal from the cervical canal (the last digit of the product code reflects its size) Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as uterine or suction curettage, labor induction, IUD placement and removal, and Radium placement
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