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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
286-0668449-7/3/1 19-Mar-2009 86HJB 3002680900 Tomey Corporation Japan
 
286-0668449-7/4/1 19-Mar-2009 86HJB 3002680900 Tomey Corporation Japan
 
286-0668449-7/2/1 19-Mar-2009 86HKY 3002680900 Tomey Corporation Japan
 
286-0668449-7/1/1 19-Mar-2009 86HLM 3002680900 Tomey Corporation Japan
 
112-5857310-7/1/1 03-Mar-2009 86HNR 3005680218 Major Surgical & Engineering Wor India
 
W24-0117793-6/16/1 25-Mar-2009 86HOH 3006497981 Ideal World International Ltd Hong Kong SAR
 
M76-9680553-1/35/1 12-Mar-2009 86HOY 3006005989 Cordova Ind Supplies United States
 
112-6423535-2/1/1 06-Mar-2009 86HQG 3007370288 Shanghai Conant Optics Co., Ltd China
 
808-0141077-2/15/1 09-Mar-2009 86HQG 3004966178 Shafa International Tools Company India
 
W24-0117793-6/15/1 25-Mar-2009 86HQY 3006497981 Ideal World International Ltd Hong Kong SAR
 
HQ7-0042050-3/1/1 11-Mar-2009 86HQZ 1000489310 Castellani S.R.L. Italy
 
HQ7-0042050-3/2/1 11-Mar-2009 86HQZ 1000489310 Castellani S.R.L. Italy
 
DO7-8352488-0/2/1 26-Mar-2009 86HQZ 3007250267 Mech Tronic Precision Manufacturing Ltd China
 
DO7-8352488-0/1/1 26-Mar-2009 86HQZ 3007250267 Mech Tronic Precision Manufacturing Ltd China
 
946-0240716-8/1/1 24-Mar-2009 86LZP 3004782462 Ophtechnics Unlimited India
 
112-6493560-5/1/1 11-Mar-2009 86NJH 3007235871 Zhenjiang Wanxin Optical Co., Ltd China
 
112-6796722-5/1/1 16-Mar-2009 86NJH 3007235871 Zhenjiang Wanxin Optical Co., Ltd China
 
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