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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-0939964-9/1/1 09-Feb-2011 78FHN 3004608878 Integra LifeSciences Corporation United States
 
UPS-1140842-0/1/1 09-Feb-2011 78FHN 3004608878 Integra LifeSciences Corporation United States
 
AEK-8364278-1/1/3 01-Feb-2011 78FHQ 3002802903 Stone Instruments Company Pakistan
 
112-9935422-8/2/1 23-Feb-2011 78FHQ 3006776838 Nct Ltd T/A Medical Innovations United Kingdom
 
FR1-0013651-9/2/1 09-Feb-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013639-4/1/1 25-Feb-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
W83-0181802-4/2/2 23-Feb-2011 78FJK 3002807744 Fresenius Medical Care Mexico
 
FR1-0013656-8/1/1 25-Feb-2011 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
112-6190309-4/1/1 23-Feb-2011 78FTQ 3008182617 Danamedic Aps Denmark
 
112-0646946-7/1/1 04-Feb-2011 78KOG 2431293 FUJINON Inc. United States
 
K51-0070634-7/1/1 08-Feb-2011 78LKN 3002427037 Haemonetics Sa Switzerland
 
112-5717923-8/1/1 23-Feb-2011 78MRE 3006440700 Contipro Pharma, a.s. Czech Republic
 
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