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

    TRUST DAM

    K Number: K091769 · Decision Feb 5, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    234

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    TRUST DAM
    K Number
    K091769
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Line One Laboratories, Inc.
    Date Received
    June 16, 2009
    Decision Date
    February 5, 2010
    Product Code
    MSC
    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
    MSC Barrier, Std, Oral Sex

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MSC), ordered by most recent decision date.

    Lorals

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SancDam Latex Oral Dam

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Harmony Latex Dam, Harmony Non-Latex Dam

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SHEER GLYDE DAMS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GLYDE DAM LOLLYES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all