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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
286-1650179-8/1/1 14-Sep-2009 86HJB 3002680900 Tomey Corporation Japan
 
286-1650179-8/3/1 14-Sep-2009 86HJB 3002680900 Tomey Corporation Japan
 
286-1650179-8/2/1 14-Sep-2009 86HJB 3002680900 Tomey Corporation Japan
 
286-1650179-8/4/1 14-Sep-2009 86HJB 3002680900 Tomey Corporation Japan
 
286-1650179-8/5/1 14-Sep-2009 86HJB 3002680900 Tomey Corporation Japan
 
112-8467336-8/1/1 01-Sep-2009 86HQG 3003268108 Thames Co., Ltd. Taiwan
 
112-8583995-0/1/1 02-Sep-2009 86HQG 3007740393 Jie Ko District China
 
N28-0126672-8/1/1 03-Sep-2009 86HQG 3003853749 Mildex Technology Inc Taiwan
 
112-8510679-8/1/1 08-Sep-2009 86HQG 3002340647 Contour Optik Inc. Taiwan
 
112-8607328-6/1/1 14-Sep-2009 86HQG 3004440039 Sun Eye Giken Co Ltd Japan
 
112-8556758-5/2/1 18-Sep-2009 86HQG 3007745242 Shunho Hui Co Ltd Taiwan
 
112-7503678-1/1/1 03-Sep-2009 86HQL 3002758032 Eagle Optics Ltd India
 
H67-1337444-4/3/1 03-Sep-2009 86HQL 2027748 Aaren Scientific, Incorporated United States
 
AEK-9923967-1/1/1 08-Sep-2009 86HQL 3005058978 Bio-Tech Vision Care Pvt India
 
H67-1337444-4/1/1 10-Sep-2009 86HQL 2027748 Aaren Scientific, Incorporated United States
 
H67-1337444-4/2/1 10-Sep-2009 86HQL 2027748 Aaren Scientific, Incorporated United States
 
112-8467336-8/2/1 01-Sep-2009 86HQY 3003268108 Thames Co., Ltd. Taiwan
 
R12-0039273-5/1/1 11-Sep-2009 86HQY 3001654059 Luxottica SRL Italy
 
AEK-9930280-0/2/1 17-Sep-2009 86HQY 3007786482 Hughes Hubbard & Reed France
 
112-8556758-5/1/1 18-Sep-2009 86HQY 3007745243 Shunho Hui Co Ltd Taiwan
 
112-8602036-0/1/1 21-Sep-2009 86HQY 3007744320 Wenzho Taili Glasses Co Ltd China
 
112-8834095-6/1/1 24-Sep-2009 86HQY 1000553820 Sun Sight Glasses Co., Ltd., Taiwan
 
112-8495269-7/1/1 02-Sep-2009 86HQZ 3005097582 Csc Labs United States
 
112-7562685-4/1/1 03-Sep-2009 86HQZ 3002711488 Ramassia United States
 
112-7209971-7/1/1 04-Sep-2009 86HQZ 3007510975 Jintong Healthcare China
 
112-9011391-2/1/1 16-Sep-2009 86HQZ 3004535542 Schnuchel Germany
 
112-8914836-6/1/1 28-Sep-2009 86HQZ 3004535542 Schnuchel Germany
 
112-7105459-8/1/1 01-Sep-2009 86LPM 3007159669 L F Garbelini Otica Me Brazil
 
WRE-5004919-6/1/1 17-Sep-2009 86NCZ 3007737829 Sang-Min Han Korea, Republic Of (South)
 
WRE-5005073-1/1/1 23-Sep-2009 86NCZ 3007619730 Beauty Supply Korea, Republic Of (South)
 
AEK-9918750-8/1/1 03-Sep-2009 86NJH 3007179600 Zhejiang Sunya China
 
112-8851946-8/1/1 22-Sep-2009 86NJH 3006287789 Polylite Taiwan Co Ltd Taiwan
 
112-8673754-2/2/1 25-Sep-2009 86NJH 3007753160 Hengpai China
 
112-9102916-6/1/1 28-Sep-2009 86NJH 3007845863 Han Min Korea Co.,Ltd Korea, Republic Of (South)
 
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