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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 112-7904083-0/1/1

Manufacturer FEI3007543858
Manufacturer NameSupro  
Manufacturer Address line 1Contiguo Gasolinera Texaco  
Manufacturer Address line 2  
Manufacturer's CityTegucigalpa  
Manufacturer Province/State  
Manufacturer Country/AreaHonduras  
Product Code76EMA  
FDA Product DescriptionCEMENT, DENTAL  
Refusal Date02-Sep-2010  
FDA DistrictFLA-DO  
Entry/doc/line/sfx 112-7904083-0/1/1
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).