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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 74-Cardiovascular


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
WRE-0328005-4/1/1 09-Apr-2005 74DQA 3003738823 Mek Co Ltd Korea, Republic Of (South)
 
AEK-7459602-0/1/1 09-Apr-2005 74DQR 3004187648 Exel Australia
 
AEK-6657941-4/1/1 13-Apr-2005 74DXY 2124215 Boston Scientific CRM Corp United States
 
AEK-6656301-2/1/1 13-Apr-2005 74DYB 3002849997 Guidant Hong Kong Limited Hong Kong SAR
 
AEK-6517776-4/2/1 07-Apr-2005 74LDE 3005009112 Full Aid Co Ltd China
 
112-6488180-6/1/1 14-Apr-2005 74LOS 3005055199 Sumbow Medical Instruments Co Ltd China
 
279-1085453-1/1/1 21-Apr-2005 74LOS 3001754919 Cortex Biophysik Gmbh Germany
 
K51-0056629-5/1/1 13-Apr-2005 74MSX 3002513440 Larsen & Toubro Ltd dba L&T Medical Equipment & Systems India
 
AEK-6656301-2/2/1 13-Apr-2005 74NIK 3002849997 Guidant Hong Kong Limited Hong Kong SAR
 
AX6-0001729-1/1/1 08-Apr-2005 74NPN 3002807720 Nihon Kohden Corp. Japan
 
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