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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
314-0201247-5/7/1 25-Jan-2013 86HKI 1000175127 Topcon Corporation Japan
 
AZW-0062616-2/1/1 31-Jan-2013 86HKX 3004451784 Huvitz Co Korea, Republic Of (South)
 
224-4188177-2/1/1 24-Jan-2013 86HQG 3009659146 Zhenjiang O Star Optial Co Ltd China
 
112-0859890-0/3/1 02-Jan-2013 86HQY 3003261430 Face A Face Architectures France
 
AEK-0316815-6/17/1 07-Jan-2013 86HQY 3009797833 Us Mototainment Llc United States
 
MY1-0908097-7/1/1 08-Jan-2013 86HQY 3007675967 LEADING HARDWARE (NINGBO) MACHINERY MFG. CO., LTD China
 
MY1-0914037-5/5/1 08-Jan-2013 86HQY 3007675967 LEADING HARDWARE (NINGBO) MACHINERY MFG. CO., LTD China
 
UPS-9273681-4/1/1 23-Jan-2013 86HQY 3002585477 Ogilvy & Mather Advertising Canada
 
MY1-0909156-0/1/1 24-Jan-2013 86HQY 3007675967 LEADING HARDWARE (NINGBO) MACHINERY MFG. CO., LTD China
 
427-7121447-7/12/1 24-Jan-2013 86HQY 3003117010 Argent Optical Manufactory Limited China
 
BUY-0009301-5/9/1 25-Jan-2013 86HQY 3009613918 Guangzhou Kinhans Industrial Co. China
 
112-0971764-0/1/1 29-Jan-2013 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
BJU-0731649-2/43/1 31-Jan-2013 86HQY 1000373939 Ferrari Spa-Es.Fabbr.Autom.E Corse Italy
 
BJU-0731649-2/44/1 31-Jan-2013 86HQY 1000373939 Ferrari Spa-Es.Fabbr.Autom.E Corse Italy
 
442-7227308-5/16/1 31-Jan-2013 86HQY 3001765203 Prophilo S.R.L. Italy
 
G51-0380974-7/7/1 31-Jan-2013 86HQY 3009818099 Ma O Ab Sweden
 
112-0859890-0/1/1 02-Jan-2013 86HQZ 3003261430 Face A Face Architectures France
 
112-0859890-0/2/1 02-Jan-2013 86HQZ 3003261430 Face A Face Architectures France
 
112-0669055-0/1/2 03-Jan-2013 86HQZ 3008994771 Iom International China
 
112-0860226-4/1/1 04-Jan-2013 86HQZ 3003261430 Face A Face Architectures France
 
112-0860226-4/2/1 04-Jan-2013 86HQZ 3003261430 Face A Face Architectures France
 
112-0860226-4/3/1 04-Jan-2013 86HQZ 3003261430 Face A Face Architectures France
 
112-0152635-3/1/1/A 23-Jan-2013 86LPL 3008070629 Maxvue Vision Sdn Bhd Malaysia
 
112-0565374-0/1/1 31-Jan-2013 86LPM 3009871244 Soleko Spa Italy
 
112-0152635-3/1/1/B 23-Jan-2013 86LPN 3008070629 Maxvue Vision Sdn Bhd Malaysia
 
112-0152635-3/1/1/C 23-Jan-2013 86LRX 3008070629 Maxvue Vision Sdn Bhd Malaysia
 
905-0941235-0/1/1 24-Jan-2013 86LZP 3004172696 C.L.R. Medicals International, Inc. United States
 
AEK-0579386-0/1/1 18-Jan-2013 86MVN 3005747991 Neo Vision Co Ltd Korea, Republic Of (South)
 
UPS-8965848-4/1/1 09-Jan-2013 86ORS 3006411077 Led Spa Italy
 
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