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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 112-4598349-4/1/1

Manufacturer FEI3006532121
Manufacturer NameGuangzhou Baiyunshan Pharmaceutical Factory  
Manufacturer Address line 1No. 88 Yunxiang Road, Tonghe Street  
Manufacturer Address line 2Baiyun District  
Manufacturer's CityGuangzhou  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code95RDZ  
Importer's Product Description509242656285 8 SCAN GREEN LASER  
Refusal Date22-Nov-2011  
FDA DistrictSAN-DO  
Entry/doc/line/sfx 112-4598349-4/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NO REGISTR   536(a); Failure to file initial report   The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).