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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
286-0666043-0/1/1 21-Aug-2007 86HJB 3002680900 Tomey Corporation Japan
 
286-0666043-0/2/1 21-Aug-2007 86HJB 3002680900 Tomey Corporation Japan
 
286-0666043-0/3/1 21-Aug-2007 86HJB 3002680900 Tomey Corporation Japan
 
286-0666043-0/4/1 21-Aug-2007 86HJB 3002680900 Tomey Corporation Japan
 
256-0283700-4/1/2 10-Aug-2007 86HKO 3004529037 Pacific Optics Electronics Co Ltd China
 
256-0283700-4/1/8 10-Aug-2007 86HKY 3004529037 Pacific Optics Electronics Co Ltd China
 
256-0283700-4/1/5 10-Aug-2007 86HLJ 3004529037 Pacific Optics Electronics Co Ltd China
 
256-0283700-4/3/1 10-Aug-2007 86HME 3004529037 Pacific Optics Electronics Co Ltd China
 
256-0283700-4/1/9 10-Aug-2007 86HOS 3004529037 Pacific Optics Electronics Co Ltd China
 
112-7278739-3/1/1 18-Aug-2007 86HQD 3002296055 Tapaszto Optic Hungary
 
AEK-7702641-3/1/1 14-Aug-2007 86HQG 3003926783 Integrated Lens Technology Pte Ltd Singapore
 
112-7254235-0/1/1/A 29-Aug-2007 86HQG 3006362803 Consultative & Commercial Center " INVET" Ukraine
 
112-7398583-0/1/1 31-Aug-2007 86HQG 3006375382 Faconnier Arts Optical Company Hong Kong SAR
 
112-7398583-0/2/1 31-Aug-2007 86HQG 3006375381 Faconnier Optical Manufactory China
 
112-7398527-7/1/1 31-Aug-2007 86HQG 3006375383 Faconnier Arts Optical Company Hong Kong SAR
 
256-0283700-4/1/10 10-Aug-2007 86HQH 3004529037 Pacific Optics Electronics Co Ltd China
 
112-7199174-9/1/1 31-Aug-2007 86HQL 3000998745 Lenstec Inc Barbados
 
256-0283700-4/1/7 10-Aug-2007 86HQZ 3004529037 Pacific Optics Electronics Co Ltd China
 
112-7515923-6/1/1 15-Aug-2007 86HQZ 3005403215 Placebo Eyewear France
 
112-7515923-6/2/1 15-Aug-2007 86HQZ 3005403215 Placebo Eyewear France
 
256-0283700-4/1/1 10-Aug-2007 86HRK 3004529037 Pacific Optics Electronics Co Ltd China
 
946-0234094-8/1/1 07-Aug-2007 86LZP 3004782462 Ophtechnics Unlimited India
 
256-0283700-4/1/3 10-Aug-2007 86MMF 3004529037 Pacific Optics Electronics Co Ltd China
 
256-0283700-4/1/4 10-Aug-2007 86MVN 3004529037 Pacific Optics Electronics Co Ltd China
 
256-0283700-4/1/6 10-Aug-2007 86MVN 3004529037 Pacific Optics Electronics Co Ltd China
 
256-0283700-4/1/11 10-Aug-2007 86MVN 3004529037 Pacific Optics Electronics Co Ltd China
 
AEK-7704272-5/1/1 24-Aug-2007 86NJH 3003926783 Integrated Lens Technology Pte Ltd Singapore
 
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