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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
K51-0062951-5/1/5 07-Jan-2008 86HJO 2000010012 Ajinomoto Trading Co.,Ltd. Japan
 
K51-0062951-5/1/1 07-Jan-2008 86HKY 1000192898 Shin Nippon Commerce, Inc. Japan
 
144-9146663-9/1/1 15-Jan-2008 86HOI 3002847807 Jisang International Korea, Republic Of (South)
 
112-0969705-4/1/1 23-Jan-2008 86HQG 3003444310 Somo Optical Co Ltd Korea, Republic Of (South)
 
112-8194830-9/1/1 28-Jan-2008 86HQG 3003615641 Essilor Of America United States
 
R12-0035965-0/1/1 15-Jan-2008 86HQY 3003116697 Safilo Group S.p.A. Italy
 
R12-0035965-0/2/1 15-Jan-2008 86HQY 3003116697 Safilo Group S.p.A. Italy
 
R12-0035965-0/3/1 15-Jan-2008 86HQY 3003116697 Safilo Group S.p.A. Italy
 
WGB-7091421-0/19/1/H 18-Jan-2008 86HQY 3006541454 Gateway Trading China
 
112-0957016-0/1/1 22-Jan-2008 86NCZ 3006630820 Zumanity United States
 
DM9-7011321-1/1/1 15-Jan-2008 86NQE 3001802794 Takagi Seiko Co. Ltd. Japan
 
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