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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 AEK-8490702-7/1/1


Manufacturer FEI3006807198
Manufacturer NameTosi Foshan Medical Equipment  
Manufacturer Address line 15-6 West Line Huanshi Dajiao  
Manufacturer Address line 2  
Manufacturer's CityGuangdong  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code76DZA  
FDA Product DescriptionDRILL, DENTAL, INTRAORAL  
Refusal Date01-Nov-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx AEK-8490702-7/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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).  
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