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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 112-4222539-4/1/1

Manufacturer FEI3007069210
Manufacturer NameWuhan Gigaa Optronics Technology Co.  
Manufacturer Address line 1II-4-502, Int'L Enterprise Center,Gua  
Manufacturer Address line 2  
Manufacturer's CityWuhan  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code79GEX  
Importer's Product Description874108226850 MEDICAL DIODE LASER SYSTEM  
Refusal Date25-Nov-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4222539-4/1/1
FDA Sample AnalysisNo  
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.