Refusal Actions by FDA as Recorded in OASIS for Finland

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


    Bioretec
    Tampere , FI                                   NOL-DO  112-0675736-4/1/1
    79L--RP   941545589046/ORTHOPEDIC TRAY
                        27-DEC-2007                        NOT LISTED