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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 86-Ophthalmic


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-2385366-7/1/1 15-May-2008 86HNR 3014865 Ocular Instruments Inc United States
 
UPS-1104950-7/1/1 19-May-2008 86HQG 3005242647 Zhenjiang Xieliang Optical Company China
 
112-2427161-2/1/1 20-May-2008 86HQG 3002340647 Contour Optik Inc. Taiwan
 
112-2512983-5/1/1 23-May-2008 86HQG 3005201290 Mildex Optical Taiwan
 
112-2518677-7/1/1 07-May-2008 86HQL 1000650934 Len Bar Barbados
 
112-2230312-8/1/1 21-May-2008 86HQY 3004360676 Safilo Spa China
 
112-2230379-7/1/1 22-May-2008 86HQY 3004360676 Safilo Spa China
 
AMG-0071098-2/6/1 29-May-2008 86HQY 3004066212 Safilo Spa Italy
 
AMG-0071098-2/5/1 29-May-2008 86HQY 3004066212 Safilo Spa Italy
 
112-2518789-0/1/1 07-May-2008 86HQZ 3006731015 Specs Trading Company Bv Netherlands
 
DO7-8717612-5/1/1 13-May-2008 86HQZ 3006735762 Td Tom Davies United Kingdom
 
112-2451054-8/1/1 14-May-2008 86HQZ 3003418134 Fortuna Optical Factory Ltd. China
 
AMG-0071098-2/2/1 29-May-2008 86HQZ 3004066212 Safilo Spa Italy
 
AMG-0071098-2/1/1 29-May-2008 86HQZ 3004066212 Safilo Spa Italy
 
AMG-0071098-2/3/1 29-May-2008 86HQZ 3004066212 Safilo Spa Italy
 
201-1370680-7/2/1 09-May-2008 86LOI 3003138580 Wavelength Laser Technologie Gmbh Germany
 
793-0603311-3/1/1 14-May-2008 86LZS 3002807715 NIDEK Co., Ltd., Hamacho Plant Japan
 
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