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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 BNW-0717680-4/11/1

Manufacturer FEI1000263418
Manufacturer NameNorthwest Airline  
Manufacturer Address line 1650-35 Nanaei Tomisato Cho  
Manufacturer Address line 2  
Manufacturer's CityChiba  
Manufacturer Province/State  
Manufacturer Country/AreaJapan  
Product Code86HQY  
Importer's Product DescriptionSUN GLASSES NON PERSCRIPTION.  
Refusal Date15-May-2007  
FDA DistrictFLA-DO  
Entry/doc/line/sfx BNW-0717680-4/11/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
REGISTERED   502(o), 801(a)(3); MISBRANDING   It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).