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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 94-Ionizing Non-Medical Devices and Components


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
233-3041904-7/5/1 12-Mar-2004 94V05 3003590913 Teradyne Incorporates P/A Van Ommeren Intexo B.V. Netherlands
 
MC2-0038991-4/3/1 11-Mar-2004 94V07 3000314628 Sony Corporation Japan
 
004-9289954-7/10/1/A 12-Mar-2004 94V07 3000174101 Nec USA Inc United States
 
TW2-0007602-8/1/1 22-Mar-2004 94V07 3000314591 Akasaka Limited Hong Kong SAR
 
406-0346515-0/1/1 22-Mar-2004 94V07 1000181100 Amac Corporation United States
 
406-0345978-1/1/1 22-Mar-2004 94V07 1000181100 Amac Corporation United States
 
406-0345978-1/2/1 22-Mar-2004 94V07 1000181100 Amac Corporation United States
 
406-0345847-8/1/1 22-Mar-2004 94V07 1000181100 Amac Corporation United States
 
406-0345847-8/4/1 22-Mar-2004 94V07 1000181100 Amac Corporation United States
 
406-0345847-8/2/1 22-Mar-2004 94V07 1000181100 Amac Corporation United States
 
406-0345847-8/3/1 22-Mar-2004 94V07 1000181100 Amac Corporation United States
 
144-3061622-9/3/1/A 30-Mar-2004 94V07 3002972643 Dell Computer (China) Co. Ltd China
 
144-3061622-9/3/1/D 30-Mar-2004 94V07 3002972643 Dell Computer (China) Co. Ltd China
 
WTA-0102514-4/1/1 31-Mar-2004 94V07 3003194422 Lg Electronics De Reynosa S.A. Mexico
 
231-1849236-4/9/1 31-Mar-2004 94V07 3002923238 Compaq Korea, Republic Of (South)
 
231-1849236-4/8/1 31-Mar-2004 94V07 3004476271 Samsung Malaysia
 
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