Refusal Actions by FDA as Recorded in OASIS for Sweden

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason


    Comfort Audio
    Halmstad , SE 302 30                           NOL-DO  112-0514329-3/1/1
    77E--SD   920901272790-HEARING DEVICE
                        14-DEC-2007                        NOT LISTED

    Comfort Audio
    Halmstad , SE 302 30                           NOL-DO  112-0514273-3/1/1
    77E--SD   920901272789-HEARING DEVICES
                        14-DEC-2007                        NOT LISTED

    Comfort Audio
    Halmstad , SE 302 30                           NOL-DO  112-0551641-5/1/1
    77L--ZI   920901272940/ASSISTIVE LISTENING DEVICES
                        18-DEC-2007                        NOT LISTED