Refusal Actions by FDA as Recorded in OASIS for Belgium

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Loreal Services Brueles , BE NYK-DO BGK-0612939-0/9/1 53KD-04 Shaving Prep, Mousse Soin De Rasage Anti-irritant 08-JUL-2008 COSMETLBLG Loreal Services Brueles , BE NYK-DO BGK-0612939-0/10/1 53KY-05 Shaving Prep, Creme Gel A Raser 08-JUL-2008 COSMETLBLG CNUDDE NV Kuurne BE-VWV, BE 8520 NOL-DO 112-3476418-4/1/1 34FFT02 863224857857 CHOCOLATE 23-JUL-2008 LACKS FIRM USUAL NAME LABELING Rainbow Flash Liezele , BE 2870 NYK-DO D04-0001295-7/1/1 80M--IO PHOTONWAVE COLOR-LIGHT THERAPY DEVICES 28-JUL-2008 NOT LISTED REGISTERED NO 510(K) Rainbow Flash Liezele , BE 2870 NYK-DO D04-0001295-7/2/1 80M--IO LIGHT THERAPY APPARATUS 28-JUL-2008 NOT LISTED REGISTERED NO 510(K)