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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 MR5-2021769-3/32/1

Manufacturer FEI3009389332
Manufacturer NameHanil Co.  
Manufacturer Address line 1127-3, Gamjeon-Dong, Sasang-Gu  
Manufacturer Address line 2  
Manufacturer's CityBusan  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53IY01  
Importer's Product DescriptionTOOTHBRUSH  
Refusal Date16-Apr-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx MR5-2021769-3/32/1
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).  
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).