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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 57-Bio & Licensed In-Vivo & In-Vitro Diag


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
UPS-0724763-0/1/1 24-Jul-2013 57PL99 3010196035 Synthes Netherlands
 
FR1-0015114-6/2/1 05-Jul-2013 57YH02 3003238685 Shanghai Amsino Medical Devices Co., Ltd. China
 
FR1-0015047-8/2/1 09-Jul-2013 57YH02 3003238685 Shanghai Amsino Medical Devices Co., Ltd. China
 
UPS-1092193-2/1/1 22-Jul-2013 57YL99 1000192002 Sanbio Bv Netherlands
 
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