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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
UPS-1671839-3/1/1 08-Apr-2011 78FCG 3003437319 Dyna Medical Canada
 
112-1465537-0/1/1 04-Apr-2011 78FEC 1000463364 Karl Storz Gmbh Co Germany
 
HG8-0132052-1/2/1 17-Apr-2011 78FEC 3008792818 Accu-Tech Co. Ltd China
 
FR1-0013762-4/1/1 04-Apr-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013738-4/1/1 06-Apr-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013744-2/2/1 11-Apr-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013638-6/5/1 13-Apr-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013694-9/1/1 13-Apr-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013698-0/1/1 13-Apr-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013717-8/3/1 17-Apr-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013638-6/3/1 13-Apr-2011 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
FR1-0013638-6/2/1 13-Apr-2011 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0013693-1/3/1 13-Apr-2011 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
FR1-0013693-1/2/1 13-Apr-2011 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0013763-2/1/1 28-Apr-2011 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0013763-2/2/1 28-Apr-2011 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
112-1166695-8/1/2 27-Apr-2011 78FTJ 3008293226 Cal Med Hungary Kft Hungary
 
AEK-8695630-3/1/1 20-Apr-2011 78FTQ 3004085452 Lanzhou Fu C I China
 
112-1166695-8/1/1 27-Apr-2011 78GCK 3008293226 Cal Med Hungary Kft Hungary
 
112-1166695-8/1/3 27-Apr-2011 78KOG 3008293226 Cal Med Hungary Kft Hungary
 
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