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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 112-4436627-9/1/1

Manufacturer FEI3008492080
Manufacturer NameShenzhen Tiande Electron Co., Ltd.  
Manufacturer Address line 1Block 2, Xiacun Block 2, Xiacun Industry  
Manufacturer Address line 2Buji Town, Longgang Dist.,  
Manufacturer's CityShenzhen  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code95RES  
Importer's Product Description877019602088 LASER  
Refusal Date30-Nov-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4436627-9/1/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
FAILS STD   501(e), 801(a)(3); ADULTERATION   The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.