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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 WT8-0310706-7/11/1

Manufacturer FEI3003113574
Manufacturer NameJacks Co  
Manufacturer Address line 13-3 Choeiji, Higashi  
Manufacturer Address line 2  
Manufacturer's CityOsaka Japan  
Manufacturer Province/StateFN  
Manufacturer Country/AreaJapan  
Product Code76EFW  
FDA Product DescriptionTOOTHBRUSH, MANUAL  
Refusal Date04-Aug-2010  
FDA DistrictLOS-DO  
Entry/doc/line/sfx WT8-0310706-7/11/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).