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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
286-0659916-6/2/1 04-Jun-2004 86HJB 3002680900 Tomey Corporation Japan
 
286-0659916-6/1/1 04-Jun-2004 86HJB 3002680900 Tomey Corporation Japan
 
K51-0054296-5/1/1 14-Jun-2004 86HKN 3004097705 Shin Nippon Commerce Inc Japan
 
AEK-6976137-3/9/1 15-Jun-2004 86HPA 3003191457 Wood Optic Diffusion Luxembourg
 
AEK-6973475-0/3/1 24-Jun-2004 86HPA 3003191457 Wood Optic Diffusion Luxembourg
 
112-3482809-3/1/1 20-Jun-2004 86HQD 1000430350 Coopervision Inc. United States
 
112-3469009-7/1/1 21-Jun-2004 86HQD 3004550163 Allen Christina Canada
 
112-3509938-9/1/1 21-Jun-2004 86HQD 3004546926 Opticas Devlyn Mexico
 
AEK-6976137-3/7/1 15-Jun-2004 86HQG 3003191457 Wood Optic Diffusion Luxembourg
 
AEK-6014167-4/3/1 18-Jun-2004 86HQG 3003191457 Wood Optic Diffusion Luxembourg
 
AEK-6973475-0/2/1 24-Jun-2004 86HQG 3003191457 Wood Optic Diffusion Luxembourg
 
754-0424613-6/2/1 18-Jun-2004 86HQY 1000469032 Wenzhou Center Optical Co., Ltd. China
 
225-2786802-4/1/1 17-Jun-2004 86HQZ 3002847344 Hoi Tat Optical Mfy., Ltd. Hong Kong SAR
 
225-2786802-4/2/1 17-Jun-2004 86HQZ 3002847344 Hoi Tat Optical Mfy., Ltd. Hong Kong SAR
 
AEK-6014167-4/5/1 18-Jun-2004 86HQZ 3003191457 Wood Optic Diffusion Luxembourg
 
112-3482809-3/2/1/A 20-Jun-2004 86HQZ 1000460458 Unknown United States
 
112-3391945-5/1/1 01-Jun-2004 86LOG 3004539891 Essex Scientific Labrotory United Kingdom
 
112-3483024-8/1/1 18-Jun-2004 86LPL 3003885021 Vistakon United States
 
112-3635255-5/1/1 22-Jun-2004 86LPL 3004570193 Vision Optika Italy
 
AEK-6014167-4/4/1 18-Jun-2004 86LPM 3003191457 Wood Optic Diffusion Luxembourg
 
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