Refusal Actions by FDA as Recorded in OASIS for New Zealand

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


    Pulsecor Ltd
    Auckland , NZ                                  NOL-DO  112-3225561-5/1/1
    74D--XN   863983844513/BLOOD PRESSURE MONITOR
                        01-AUG-2008                        NOT LISTED
                                                           NO 510(K)

    Shop New Zealand
    Auckland , NZ                                  NOL-DO  112-1746313-5/1/1
    54YCB99   VIta Fit-Growth hormone releaser
                        21-AUG-2008                        HEALTH C