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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
AEK-8953525-2/1/1 07-Feb-2012 78FFE 3009265325 Minch Co Ltd China
 
T94-0056591-5/7/1 13-Feb-2012 78FHI 1000157602 Medicon Instrumente Germany
 
AEK-8393422-0/1/3 15-Feb-2012 78FHQ 3002914520 Solatch International Pakistan
 
WC1-8455136-2/220/1 23-Feb-2012 78FHQ 2433092 Fine Surgical Instruments, Inc. United States
 
FR1-0014216-0/3/1 13-Feb-2012 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0014253-3/2/1 21-Feb-2012 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0014255-8/2/1 21-Feb-2012 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
T94-0056591-5/1/3 13-Feb-2012 78KOA 1000157602 Medicon Instrumente Germany
 
T94-0056591-5/1/1 13-Feb-2012 78KOA 1000157602 Medicon Instrumente Germany
 
UPS-5300038-2/1/1 09-Feb-2012 78KOG 3006756890 Proxy Biomedical Ltd Ireland
 
EE1-0038359-9/2/1 07-Feb-2012 78LKY 3009176951 Dongguan Joygrace Electronic Co.Ltd China
 
EE1-0038359-9/2/2 07-Feb-2012 78LKY 3009176951 Dongguan Joygrace Electronic Co.Ltd China
 
AEK-0257347-1/2/1 29-Feb-2012 78LKY 3009424620 Shenzhen Huirun Import & Export Co China
 
K80-1006443-5/1/2 23-Feb-2012 78LYW 3009250934 Shiquline Int'L Co Ltd. Hong Kong SAR
 
334-2767321-6/1/1 08-Feb-2012 78OGM 3002807877 Hameln Pharmaceuticals Gmbh Germany
 
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