Refusal Actions by FDA as Recorded in OASIS for Malta & Gozo

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


    Phalomed Manufacturing
    San Gwann , MT SGN09                           CIN-DO  AEK-9065642-8/1/1
    78N--HU   PENIS ENLARGMENT DEVICE FOR PERSONAL USE
                        12-DEC-2007                        NOT LISTED
                                                           NO 510(K)