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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
E10-0208456-7/1/1 31-May-2012 78KOG 3009522935 Sanitas Lab Technology Colombia
 
112-6625008-8/1/1 02-May-2012 78LKY 3006891790 ANDROMEDICAL SL Spain
 
AEK-0273987-4/1/1 01-May-2012 78LYW 3009491623 Mustapha Abdul Mujees Ghana
 
112-7235420-5/1/1 25-May-2012 78MRE 3009492567 Hangzhou Singclean Medical Produ China
 
112-6844539-7/1/1 17-May-2012 78NHU 3005615971 ORBISAN LTD Malta & Gozo
 
112-6844455-6/1/1 17-May-2012 78NHU 3005615971 ORBISAN LTD Malta & Gozo
 
112-6917903-7/1/1 17-May-2012 78NHU 3005615971 ORBISAN LTD Malta & Gozo
 
112-6947246-5/1/1 17-May-2012 78NHU 3005615971 ORBISAN LTD Malta & Gozo
 
112-6914066-6/1/1 17-May-2012 78NHU 3005615971 ORBISAN LTD Malta & Gozo
 
112-6844380-6/1/1 17-May-2012 78NHU 3005615971 ORBISAN LTD Malta & Gozo
 
112-6844610-6/1/1 17-May-2012 78NHU 3005615971 ORBISAN LTD Malta & Gozo
 
112-6917836-9/1/1 23-May-2012 78NHU 3005615971 ORBISAN LTD Malta & Gozo
 
112-6914456-9/1/1 23-May-2012 78NHU 3005615971 ORBISAN LTD Malta & Gozo
 
XXX-0284439-8/1/1 09-May-2012 78OCT 2936485 Stryker Endoscopy United States
 
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