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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
EE3-1119306-8/1/1 28-Oct-2004 86HJO 3000200843 Appasamy Associates India
 
EE3-1111911-3/1/1 05-Oct-2004 86HOI 1000645512 Winsor Optical International Co., Ltd. China
 
112-4225459-7/1/1 17-Oct-2004 86HOI 3004644095 Low Vision Center Of Indianapoli United States
 
HL3-9041419-7/6/1 23-Oct-2004 86HOI 3004715641 Lamiss Intertrade Co Ltd Thailand
 
582-0517978-2/1/1 27-Oct-2004 86HOI 2020853 Younger Mfg Company dba Younger Optics United States
 
AEK-6994277-5/6/1 26-Oct-2004 86HPA 3003185152 Gold & Wood Luxembourg
 
AEK-6994276-7/9/1 26-Oct-2004 86HPA 3003185152 Gold & Wood Luxembourg
 
AEK-6994278-3/10/1 26-Oct-2004 86HPA 3003185152 Gold & Wood Luxembourg
 
AEK-6994278-3/16/1 26-Oct-2004 86HPA 3003185152 Gold & Wood Luxembourg
 
112-4169118-7/1/1 14-Oct-2004 86HQD 3004637849 Swiss Eye International Germany
 
112-4211099-7/1/1 17-Oct-2004 86HQD 3004560106 Autos Pulman Sa De Cv Mexico
 
112-4285698-7/1/1 22-Oct-2004 86HQD 3004360473 Metamorph Gmbh Germany
 
112-4410591-2/1/1 31-Oct-2004 86HQD 1000222023 Johnson & Johnson Vision Care, Inc. United States
 
ND7-0023360-1/1/1 06-Oct-2004 86HQG 3002838301 China Ningbo Cixi Import & Export Corporation China
 
AEK-6447181-2/1/1 13-Oct-2004 86HQG 1000547432 Han Dok Alps Optical Co., Ltd Korea, Republic Of (South)
 
112-4224960-5/1/1 17-Oct-2004 86HQG 3003605540 Otimpor Ca Venezuela
 
AEK-6994277-5/5/1 26-Oct-2004 86HQG 3003185152 Gold & Wood Luxembourg
 
AEK-6994276-7/8/1 26-Oct-2004 86HQG 3003185152 Gold & Wood Luxembourg
 
AEK-6994278-3/9/1 26-Oct-2004 86HQG 3003185152 Gold & Wood Luxembourg
 
AEK-6994278-3/15/1 26-Oct-2004 86HQG 3003185152 Gold & Wood Luxembourg
 
112-4339519-1/1/1 28-Oct-2004 86HQL 3003833494 Hanita Lenses Israel
 
112-4244779-5/1/1/B 18-Oct-2004 86HQY 3003775637 Coastal Contact Canada
 
U79-0041411-2/1/1 25-Oct-2004 86HQY 1000353898 Zhejiang Wenzhou Metals And Min China
 
112-4192621-1/1/1 15-Oct-2004 86HQZ 3003206311 Optix Sports Canada
 
548-0116462-2/1/1 25-Oct-2004 86HQZ 3909 Elegance Optical Manufactory, Ltd. Hong Kong SAR
 
548-0116462-2/2/1 25-Oct-2004 86HQZ 3003980846 Skyey Optical Mfy Hong Kong SAR
 
548-0116462-2/3/1 25-Oct-2004 86HQZ 3004482375 Genuine International Optical Limit Hong Kong SAR
 
548-0116462-2/5/1 25-Oct-2004 86HQZ 3001028071 New Optics Manufacturing Hong Kong SAR
 
AEK-6433115-6/1/1 01-Oct-2004 86LPL 1000281251 Kawasaki Heavy Industries, Ltd. Japan
 
112-4285693-8/1/1 21-Oct-2004 86LPL 1000266844 Odesa S.A. De C.V. Mexico
 
112-4371054-8/1/1 29-Oct-2004 86LPL 3004710706 Taye Garrick Nigeria
 
112-4385483-3/1/1 31-Oct-2004 86LPL 3002984113 M. Carpmon Canada
 
112-4285698-7/2/1 22-Oct-2004 86MSI 3004360473 Metamorph Gmbh Germany
 
112-4244779-5/1/1/A 18-Oct-2004 86MWL 3000245447 Ciba Vision Indonesia
 
112-4244779-5/1/1/C 18-Oct-2004 86MWL 1000222023 Johnson & Johnson Vision Care, Inc. United States
 
AEK-6454012-9/1/1 22-Oct-2004 86NIC 3004778746 New Bio Co Ltd Korea, Republic Of (South)
 
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