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

    LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM

    K Number: K021012 · Decision Jun 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    88

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    Basic Information

    Device Name
    LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
    K Number
    K021012
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4260
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quality Medical Solusions, LLC
    Date Received
    March 29, 2002
    Decision Date
    June 25, 2002
    Product Code
    HDY
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HDY Dilator, Cervical, Hygroscopic-Laminaria

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