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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-4077881-9/1/1


Manufacturer FEI3008038514
Manufacturer NameWicked Lasers  
Manufacturer Address line 1Rm 105 No.9 Lane 89 An Shun Rd  
Manufacturer Address line 2  
Manufacturer's CityShanghaishanghai  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code95RDW  
FDA Product DescriptionGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL  
Refusal Date02-Nov-2011  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-4077881-9/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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).  
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