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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
286-0659364-9/1/1 28-Jan-2004 86HJB 3002680900 Tomey Corporation Japan
 
286-0659364-9/2/1 28-Jan-2004 86HJB 3002680900 Tomey Corporation Japan
 
582-1942673-1/1/1 29-Jan-2004 86HPA 3003191457 Wood Optic Diffusion Luxembourg
 
N28-0097521-2/1/1 08-Jan-2004 86HQD 1118577 CooperVision, Inc. United States
 
112-2294485-2/1/1 30-Jan-2004 86HQD 3004371579 Gabriel Baranda United States
 
AEK-6307690-1/1/1 21-Jan-2004 86HQL 6105 Ophtec B.V. Netherlands
 
112-2197492-6/1/1 03-Jan-2004 86HQY 3003098076 Premier Optical MFY. LTD. Hong Kong SAR
 
112-2273970-8/1/1 06-Jan-2004 86HQY 3003991081 Danor Srl Italy
 
112-2208556-5/1/1 09-Jan-2004 86HQY 3003837870 Premier Optical Manufactory China
 
112-2219826-9/3/1 09-Jan-2004 86HQY 3003098076 Premier Optical MFY. LTD. Hong Kong SAR
 
310-9155672-5/2/1 13-Jan-2004 86HQY 3003696688 Blue Gem United States
 
310-9155672-5/3/1 13-Jan-2004 86HQY 3003696688 Blue Gem United States
 
WYT-0037805-3/6/1 29-Jan-2004 86HQY 3003206030 Dfass Jamaica Limited Jamaica
 
WIB-1170892-5/1/1 30-Jan-2004 86HQY 6548 Raymond Chu International Limited (Raymchu) Hong Kong SAR
 
AEK-6309669-3/1/1 30-Jan-2004 86HQY 3004372962 P14 Wenzhou Hongbang Glasses China
 
MC2-0534206-6/4/1 27-Jan-2004 86HQZ 3002776786 Seiko Contaclens Inc Japan
 
WIB-1173935-9/1/1 29-Jan-2004 86HQZ 3003098076 Premier Optical MFY. LTD. Hong Kong SAR
 
W92-0074477-4/1/1 08-Jan-2004 86LPL 3003539765 Mikwang Contact Lens Co Ltd Korea, Republic Of (South)
 
W92-0075036-7/1/1 08-Jan-2004 86LPL 3003539765 Mikwang Contact Lens Co Ltd Korea, Republic Of (South)
 
KC1-4703560-6/1/1 23-Jan-2004 86LPL 1000419454 Con Ltd United Kingdom
 
MV4-0005004-8/2/1/C 07-Jan-2004 86LPM 3001570377 Aspect Vision Care Ltd United Kingdom
 
582-1685300-2/1/1 29-Jan-2004 86MVN 3003046373 Neher Cargo Service Netherlands
 
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