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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 231-1203550-0/1/1

Manufacturer FEI3003412022
Manufacturer NameShenzhen Breo Technology Co., Ltd  
Manufacturer Address line 1Rm. 2202, 22/F Jinshan Bldg.  
Manufacturer Address line 2No. 5033, Shennan East Rd  
Manufacturer's CityShenzhen, Guangdong  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code89ISA  
Importer's Product DescriptionIDREAM HEAD MASSAGER  
Refusal Date17-Aug-2010  
FDA DistrictCIN-DO  
Entry/doc/line/sfx 231-1203550-0/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
FALSE   502(a), 801(a)(3); MISBRANDING   The labeling for this article appears to be false or misleading