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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
112-5874746-1/1/1/A 29-Jul-2009 78EZD 3002807725 Nipro Medical Industries, Ltd. Japan
 
112-6132087-6/1/1 31-Jul-2009 78FAJ 3004640478 Medecis France
 
FR1-0012752-6/1/1 31-Jul-2009 78FAQ 3003279193 Amsino Medical Instrument Co Ltd China
 
FR1-0012742-7/1/1 22-Jul-2009 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0012746-8/1/1 22-Jul-2009 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0012759-1/1/1 22-Jul-2009 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0012743-5/1/1 22-Jul-2009 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
112-6137615-9/1/1 31-Jul-2009 78KOG 3007321321 Lut Gmbh Labor U. Umwelttechn. Germany
 
K51-0067043-6/1/1 08-Jul-2009 78LKN 3007628703 Maco Spania Sl Spain
 
112-8201976-2/1/1/A 24-Jul-2009 78MHU 3007676875 Aeon Astron Europe B.V. Netherlands
 
112-8201976-2/1/1/B 24-Jul-2009 78MHU 3007676875 Aeon Astron Europe B.V. Netherlands
 
UPS-5174750-7/1/1 14-Jul-2009 78NHU 3006891323 X4 Labs Inc. Canada
 
112-8370371-1/1/1 27-Jul-2009 78NYJ 3006212544 Sewoon Medical Co., Ltd Korea, Republic Of (South)
 
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