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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
T94-0054359-9/1/1 21-Dec-2010 78FAR 3008384448 Beful Co. Ltd Korea, Republic Of (South)
 
336-1044718-0/1/10 30-Dec-2010 78FCG 3003044010 Hs Hospital Service Srl Italy
 
336-1044718-0/1/24 30-Dec-2010 78FCG 3003044010 Hs Hospital Service Srl Italy
 
112-9602807-3/1/1 15-Dec-2010 78FGB 3006650154 Endosource Inc Canada
 
UPS-0766740-1/1/1 30-Dec-2010 78FHN 3004608878 Integra LifeSciences Corporation United States
 
AEK-8359008-9/1/4 30-Dec-2010 78FHQ 1000279168 Dr. Frigz International (Pvt.) Ltd. Pakistan
 
FR1-0013582-6/1/1 28-Dec-2010 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013581-8/2/1 30-Dec-2010 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013590-9/1/1 28-Dec-2010 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0013590-9/2/1 28-Dec-2010 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
HL3-9102238-7/1/1 10-Dec-2010 78FLA 3008517692 Xltek Canada
 
112-9446899-0/1/2 03-Dec-2010 78GCT 2431764 Designs For Vision United States
 
112-9816587-3/1/1 10-Dec-2010 78GDB 3005655400 Ningbo Sunny China
 
510-1135572-7/1/1 13-Dec-2010 78KDI 3006895070 Asahi Kasei Pharma Corporation Diagnostics Dept. Japan
 
112-9993058-0/1/1 06-Dec-2010 78KOG 3008664544 Shenyang Shenda Endoscope Co., Ltd. China
 
112-9797893-8/1/1 08-Dec-2010 78KOG 3008656794 Shanghai Outai Medical Equipment Co. Ltd. China
 
112-9816587-3/2/1 10-Dec-2010 78KOG 3005655400 Ningbo Sunny China
 
AWM-0017150-6/2/1 30-Dec-2010 78KOG 3008635542 Hilomast United Kingdom
 
AWM-0017150-6/2/2 30-Dec-2010 78KOG 3008635542 Hilomast United Kingdom
 
K51-0070810-3/1/1 17-Dec-2010 78LIF 3008693825 Esteril Sa De Cv Mexico
 
XXX-0174388-0/1/1 07-Dec-2010 78NWB 3002808148 Shirakawa Olympus Co., Ltd. Japan
 
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