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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 90-Radiological


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-0477692-2/1/1 13-Dec-2012 90ITX 3009234356 Esaote Italy
 
112-9823072-8/1/1 03-Dec-2012 90IWQ 3003757292 W.S. Rothband & Co., Ltd. United Kingdom
 
336-7460996-5/1/1 10-Dec-2012 90IWY 3002808529 GE Healthcare Japan Corporation Japan
 
336-7460996-5/1/2 10-Dec-2012 90IWY 3002808529 GE Healthcare Japan Corporation Japan
 
MH9-2007271-6/1/1 10-Dec-2012 90IZG 3004453295 Dongmun Co., Ltd Korea, Republic Of (South)
 
MH9-2007271-6/1/2 10-Dec-2012 90IZG 3004453295 Dongmun Co., Ltd Korea, Republic Of (South)
 
MH9-2007352-4/1/1 10-Dec-2012 90IZH 3004453295 Dongmun Co., Ltd Korea, Republic Of (South)
 
MH9-2006277-4/1/1 03-Dec-2012 90JAC 3005435248 Huqiu Imaging Tech China
 
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