Refusal Actions by FDA as Recorded in OASIS for Hong Kong SAR

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
New Medical Ltd Wanchai Hk , HK SAN-DO 112-4298874-2/1/1 79M--DM 861294829060 MICRO NEEDLE ROLLER 03-OCT-2008 NOT LISTED REGISTERED Prosperity Lamps & Components Limited Hong Kong , HK ATL-DO 336-7982440-2/3/1 95R--DY MERCURY VAPOR METAL HALIDE LAMP 07-OCT-2008 NO REGISTR Prosperity Lamps & Components Limited Hong Kong , HK ATL-DO 336-7982440-2/3/2 95R--DY MERCURY VAPOR METAL HALIDE LAMP 07-OCT-2008 NO REGISTR Chu Kong Optical Manufactory Ltd Kwai Chung , HK CHI-DO E74-0206126-1/2/1 86H--QZ P[LASTIC FRAME 14-OCT-2008 NOT LISTED Chu Kong Optical Manufactory Ltd Kwai Chung , HK CHI-DO E74-0206126-1/3/1 86H--QZ METAL FRAME 14-OCT-2008 NOT LISTED Chu Kong Optical Manufactory Ltd Kwai Chung , HK CHI-DO E74-0206126-1/1/1 86H--QY SUNGLASSES 14-OCT-2008 NOT LISTED NOT IMPACT Digway Limited Hong Kong , HK FLA-DO 113-4430690-4/1/1 95R--HD CATEGORY:VIDEO, BRAND:CROSLEY BRAND (NON-USA), DESC:DVD PLAY 20-OCT-2008 NON STD Sun Ming Hong Hong Kong , HK 9999 NYK-DO W24-0117291-1/1/1 16EGH04 MUSSELS;PLASTIC, SYNTH;NTRL/ARTFCL DRIED 29-OCT-2008 SALMONELLA Wing Tai Trading Company Sai Kung , HK NYK-DO KM6-0038082-8/16/2 21HGT14 DRIED PLUM 29-OCT-2008 UNSAFE COL FILTHY CYCLAMATE DULCIN SACCHARIN Wing Tai Trading Company Sai Kung , HK NYK-DO KM6-0038082-8/16/1 21HGT14 DRIED PLUM 29-OCT-2008 UNSAFE COL FILTHY CYCLAMATE DULCIN SACCHARIN Sing Kwong Trading Company Kowloon , HK LOS-DO AEK-9696613-6/1/1 89I--SA SKIN SCRUBBER(FORMAL ENTRY PER FDA REQUESTED) 31-OCT-2008 NOT LISTED REGISTERED NO 510(K) Sing Kwong Trading Company Kowloon , HK LOS-DO AEK-9696613-6/1/2 89I--SA MICRODERMABRASION MACHINE(FORMAL ENTRY PER FDA REQUESTED) 31-OCT-2008 NOT LISTED REGISTERED NO 510(K) Sing Kwong Trading Company Kowloon , HK LOS-DO AEK-9696613-6/1/3 89I--SA BREAST MASSAGE DEVICE(FORMAL ENTRY PER FDA REQUESTED) 31-OCT-2008 NO 510(K) Sing Kwong Trading Company Kowloon , HK LOS-DO AEK-9696613-6/1/4 89I--SA PHOTON LED DEVICE(FORMAL ENTRY PER FDA REQUESTED) 31-OCT-2008 NOT LISTED REGISTERED Sing Kwong Trading Company Kowloon , HK LOS-DO AEK-9696613-6/1/5 89I--SA MICRO CURRENT MACHINE(FORMAL ENTRY PER FDA REQUESTED) 31-OCT-2008 NO 510(K)