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-9432052-6/1/1 89L--YG MASSAGE APPARATUS 13-MAR-2008 NOT LISTED DIRECTIONS NO 510(K)