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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 XXX-0176436-5/1/1/D


Manufacturer FEI3009177805
Manufacturer NameYIWU ACME  
Manufacturer Address line 1NO. 525 CAIFU BUILDING  
Manufacturer Address line 2  
Manufacturer's CityYIWU CITY  
Manufacturer Province/StateZHEJIANG  
Manufacturer Country/AreaChina  
Product Code95REA  
FDA Product DescriptionHIGH-POWER LASER LIGHT SHOW PROJECTOR (OUTPUT>5MW)  
Refusal Date30-Nov-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx XXX-0176436-5/1/1/D
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).  
NO TAG   536(a),(b); NOT CERTIFIED   It appears that the article does not have affixed to it a certification in the form of a label or tag in conformity with section 534(h).  
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