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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-9374559-0/2/1 30-Jan-2013 78FAS 3009991890 Serp France
 
FR1-0014642-7/1/1 07-Jan-2013 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0014774-8/1/1 07-Jan-2013 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0014774-8/2/1 07-Jan-2013 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
FR1-0014718-5/1/1 07-Jan-2013 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0014718-5/2/1 07-Jan-2013 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
112-0794722-3/1/1 17-Jan-2013 78KOG 2429304 Olympus America Inc. United States
 
HG8-0139692-7/1/1 29-Jan-2013 78KOG 3004378299 Quanta System, S.p.A. Italy
 
AEK-0772850-0/1/1 15-Jan-2013 78LKY 3008023386 Cyrex Limited United Kingdom
 
AEK-0771765-1/1/1 15-Jan-2013 78LKY 3008023386 Cyrex Limited United Kingdom
 
112-1140773-5/1/1 29-Jan-2013 78LKY 3008722819 Lh Trading Ltd United Kingdom
 
EG6-2791092-0/1/1/A 22-Jan-2013 78LST 3008247701 Lubecki Technical Holdings, Inc. Canada
 
EG6-2791092-0/1/1/B 22-Jan-2013 78LST 3008247701 Lubecki Technical Holdings, Inc. Canada
 
WSU-0015778-0/1/1 02-Jan-2013 78OCS 3009866357 Hoya Pentax Japan
 
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