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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 78-Gastroenterological & Urological


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
FR1-0012921-7/1/2 08-Dec-2009 78FAQ 3003279193 Amsino Medical Instrument Co Ltd China
 
004-5310523-1/2/1 16-Dec-2009 78FJK 3002806727 Gambro Renal Products S.A. de C.V. Mexico
 
FR1-0012986-0/1/1 05-Dec-2009 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
FR1-0012966-2/2/1 05-Dec-2009 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0012966-2/3/1 05-Dec-2009 78FKP 3002808905 Nikkiso Co., Ltd. (Headquarters) Japan
 
FR1-0012966-2/4/1 05-Dec-2009 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
FR1-0012910-0/1/1 08-Dec-2009 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
AEK-8034436-5/1/1 10-Dec-2009 78JCW 3006205650 Lativio Llp United Kingdom
 
AEK-8031877-3/1/1 28-Dec-2009 78JCW 3006205650 Lativio Llp United Kingdom
 
AEK-8025425-9/1/1 07-Dec-2009 78LKY 3006205650 Lativio Llp United Kingdom
 
AEK-8031876-5/1/1 07-Dec-2009 78LKY 3008008389 Andre Felipe Creque United States
 
AEK-8031874-0/1/1 28-Dec-2009 78LKY 3006205650 Lativio Llp United Kingdom
 
AEK-8027430-7/1/1 28-Dec-2009 78LKY 3006205650 Lativio Llp United Kingdom
 
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