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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal FR1-0013946-3/1/1


Manufacturer FEI3007363456
Manufacturer NameTianjin Hanaco Xingda Medical Co., Ltd.  
Manufacturer Address line 1No. 4, QIJING ROAD  
Manufacturer Address line 2DONGLI ECONOMIC DEVELOPMENT Zone  
Manufacturer's CityTIANJIN  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code80FRN  
Importer's Product DescriptionINFUSION SET FOR EXPORT ONLY  
Refusal Date14-Nov-2011  
FDA DistrictFLA-DO  
Entry/doc/line/sfx FR1-0013946-3/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
REGISTERED   502(o), 801(a)(3); MISBRANDING   It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).  
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