BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    MODIFICATION TO URESTA PESSARY

    K Number: K083769 · Decision Jan 14, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    40
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    MODIFICATION TO URESTA PESSARY
    K Number
    K083769
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.3575
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eastmed, Inc.
    Date Received
    December 18, 2008
    Decision Date
    January 14, 2009
    Product Code
    HHW
    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
    HHW Pessary, Vaginal

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    Other Clearances by Eastmed, Inc.

    K Number Device Name
    K081385 URESTA PESSARY