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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
FR1-0013085-0/1/2 01-Mar-2010 78FAQ 3003279193 Amsino Medical Instrument Co Ltd China
 
788-0711373-0/1/1 23-Mar-2010 78FAQ 3003782560 Changshu Medical Appliance Factory China
 
112-7944551-7/1/1 10-Mar-2010 78FBQ 3007327966 Shanghai Top Resources Imp. & Exp. Co., Ltd. China
 
788-0711373-0/3/1 23-Mar-2010 78FCM 3005596530 Conod Medical Co., Limited China
 
AEK-8006541-6/1/4 05-Mar-2010 78FHQ 3006784628 Hi Tech International Pakistan
 
AEK-8009978-7/2/1 13-Mar-2010 78FHQ 3007835026 Moonica Fabrics Pakistan
 
FR1-0013080-1/1/1 01-Mar-2010 78FJI 3007245589 Shibuya Kogyo Co Ltd Japan
 
FR1-0013114-8/1/1 09-Mar-2010 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013125-4/1/1 09-Mar-2010 78FKP 3002808905 Nikkiso Co., Ltd. (Headquarters) Japan
 
FR1-0013125-4/2/1 09-Mar-2010 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
UPS-7363893-2/1/1 26-Mar-2010 78LST 3008170360 Versa Plastics Canada
 
AEK-9642327-8/1/1 17-Mar-2010 78MNV 3007908116 Yercon Diagnostic Co Ltd China
 
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