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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
112-3737582-4/1/1 06-Dec-2011 78EXZ 3009091297 Alba Fotonica Spain
 
112-4789179-4/1/1 09-Dec-2011 78EYQ 3004500351 Sca North America - Canada Inc Canada
 
112-4864354-1/1/1 09-Dec-2011 78EYQ 3004500351 Sca North America - Canada Inc Canada
 
112-4986316-3/2/1 16-Dec-2011 78EYQ 3009181089 Netti A S Denmark
 
112-7560436-5/1/1 30-Dec-2011 78FDS 3007108742 Medicus Maximus Ltd United Kingdom
 
112-2151609-4/1/5 12-Dec-2011 78FHQ 3004968149 Rz Medizintech Gmbh Germany
 
112-2328249-7/1/1 28-Dec-2011 78FHQ 3006506629 M/s Health Mission Instruments Pakistan
 
FR1-0014207-9/1/1 14-Dec-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0014161-8/2/1 21-Dec-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0014141-0/1/1 05-Dec-2011 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
112-2616514-5/1/1 07-Dec-2011 78KOA 3008958847 Proaccion Soc De B Argentina
 
NS1-0007717-2/1/1 23-Dec-2011 78KOG 3009195913 Fuji Trading Co Ltd Japan
 
112-3380763-0/1/1 28-Dec-2011 78LKY 3006779732 Rocks Off Ltd United Kingdom
 
112-0511810-7/1/1 13-Dec-2011 78LNT 3006946925 Tissuemed Limited United Kingdom
 
112-4344446-5/1/1 28-Dec-2011 78MSD 3005612924 Cardiomed Supplies, Inc. Canada
 
AEK-8963895-7/1/1/C 19-Dec-2011 78NHU 2246912 Vita Pure Inc United States
 
112-9914500-6/1/1 13-Dec-2011 78OCZ 3007990855 Horizon International Corporatio Costa Rica
 
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