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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
BQL-0031957-2/3/2/E 01-Feb-2013 78FCE 3005597802 Unknown Russia
 
BQL-0031957-2/3/2/F 01-Feb-2013 78FCE 3005597802 Unknown Russia
 
112-0607303-9/1/1 04-Feb-2013 78FCE 3008530452 SOULGENIE HEALTH PATHWAYS LLP India
 
600-6332702-1/1/1 27-Feb-2013 78FFY 3007916061 Bags And Gloves Co Ltd Thailand
 
600-6332702-1/2/1 27-Feb-2013 78FFY 3007916061 Bags And Gloves Co Ltd Thailand
 
T94-0058190-4/4/2 01-Feb-2013 78FIH 3009548041 Sino-Hero (Shenzhen) Bio-Medical Electronics Co, China
 
T94-0058190-4/4/3 01-Feb-2013 78FIH 3009548041 Sino-Hero (Shenzhen) Bio-Medical Electronics Co, China
 
FR1-0014678-1/4/1 01-Feb-2013 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0014630-2/2/1 01-Feb-2013 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
FR1-0014630-2/1/1 01-Feb-2013 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
HG8-0139691-9/1/1 05-Feb-2013 78KOG 3004378299 Quanta System, S.p.A. Italy
 
112-1133509-2/1/1 11-Feb-2013 78KPL 3009955794 Guangzhou Chuanghuan Ozone Electric China
 
AEK-0786468-5/2/4 05-Feb-2013 78LKY 3009695667 Moon Well China
 
AEK-0786468-5/3/14 05-Feb-2013 78LKY 3009695667 Moon Well China
 
AEK-0786468-5/3/15 05-Feb-2013 78LKY 3009695667 Moon Well China
 
AEK-0786468-5/3/22 05-Feb-2013 78LKY 3009695667 Moon Well China
 
AEK-0786468-5/3/23 05-Feb-2013 78LKY 3009695667 Moon Well China
 
AEK-0786468-5/3/12 05-Feb-2013 78LKY 3009695667 Moon Well China
 
AEK-0786468-5/3/13 05-Feb-2013 78LKY 3009695667 Moon Well China
 
AEK-0786468-5/3/11 05-Feb-2013 78LKY 3009695667 Moon Well China
 
AEK-0771610-9/1/1 13-Feb-2013 78LKY 3008023386 Cyrex Limited United Kingdom
 
AEK-0784836-5/1/1 19-Feb-2013 78LKY 3008676789 Lemei Technology Co.,Ltd China
 
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