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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 UPS-4124671-7/1/1

Manufacturer FEI3009187600
Manufacturer NameDaheng Precision Mechanical Co.Ltd  
Manufacturer Address line 19fl, Building 7, Lane 41 Sanyuan  
Manufacturer Address line 2  
Manufacturer's CityShanghaishi  
Manufacturer Province/StateShanghaishi  
Manufacturer Country/AreaChina  
Product Code95RDW  
Importer's Product DescriptionLASER PEN FOR PERSONAL USE / ERR CBP  
Refusal Date14-Nov-2011  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-4124671-7/1/1
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).