Refusal Actions by FDA as Recorded in OASIS for South Africa

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


    Nu Angle Medical
    Johannesburg , ZA                              NOL-DO  112-0413975-5/1/1
    79L--CJ   855492710423    EXPANDER
                        12-DEC-2007                        NOT LISTED
                                                           NO 510(K)

    Laboratory & Scientific Eqpmt
    Cape Town , ZA 8000                            NOL-DO  112-0496097-8/1/1
    79F--MK   861870956043/LANCET
                        13-DEC-2007                        NOT LISTED

    Trade Avail 164cc
    Caledon , ZA 7230                              LOS-DO  190-4030742-3/1/1
    54FBR99   Hoodia Gordonii Powder
                        18-DEC-2007                        UNSFDIETSP

    Trade Avail 164cc
    Caledon , ZA 7230                              LOS-DO  190-4030808-2/1/1
    54FBR99   Hoodia Gordonii Powder
                        18-DEC-2007                        UNSFDIETSP