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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 275-1421292-0/4/1


Manufacturer FEI3000368601
Manufacturer NameSds De Mexico Sa De Cv  
Manufacturer Address line 1Circuito Sur No 31 Pque Ind Nelson  
Manufacturer Address line 2  
Manufacturer's CityMexicali B C  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code76ECI  
FDA Product DescriptionBAND, ELASTIC, ORTHODONTIC  
Refusal Date23-Sep-2010  
FDA DistrictLOS-DO  
Entry/doc/line/sfx 275-1421292-0/4/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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).  
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