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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 MH9-0097852-8/1/1

Manufacturer FEI3008816886
Manufacturer NameWuxi Haiying International Trade Co  
Manufacturer Address line 118 Liangxi Road  
Manufacturer Address line 2  
Manufacturer's CityJiangsu  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code84GXX  
Importer's Product DescriptionULTRASONIC UNIT  
Refusal Date28-Nov-2011  
FDA DistrictFLA-DO  
Entry/doc/line/sfx MH9-0097852-8/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).