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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
499-0134184-9/3/1 14-Aug-2013 90ITX 3004705634 Sonoscape Company, Ltd. China
 
AEK-9200784-4/1/1 07-Aug-2013 90IYN 3010310145 Lucio Mele Elettromedicali Italy
 
499-0134184-9/2/1 14-Aug-2013 90IYN 3004705634 Sonoscape Company, Ltd. China
 
322-0916607-7/1/1 14-Aug-2013 90IYO 3002619337 Siemens Ltd. Seoul Korea, Republic Of (South)
 
499-0134184-9/1/1 14-Aug-2013 90IYO 3004705634 Sonoscape Company, Ltd. China
 
UPS-1704797-1/1/1 19-Aug-2013 90IZL 3008638070 Moshe Glam Israel
 
U35-3530411-8/1/1 29-Aug-2013 90JAA 3009689910 Intermedical S.R.L Unipersonale Italy
 
BWR-0067178-0/1/1 21-Aug-2013 90JAK 3002723829 Hoyu Co Ltd Japan
 
261-0164154-1/1/1 15-Aug-2013 90LSY 3010143383 Hitachi Medical System (S) Pte Ltd Singapore
 
112-3448838-1/1/1 16-Aug-2013 90LXE 3008973759 SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD China
 
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