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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 BOU-1014677-8/1/1

Manufacturer FEI3003061923
Manufacturer NameMadespa S.A.  
Manufacturer Address line 1Rio Jarama, 120  
Manufacturer Address line 2  
Manufacturer's CityToledo  
Manufacturer Province/State  
Manufacturer Country/AreaSpain  
Product Code76EMA  
FDA Product DescriptionCEMENT, DENTAL  
Refusal Date03-Sep-2010  
FDA DistrictSJN-DO  
Entry/doc/line/sfx BOU-1014677-8/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
RECORDS   502(t), 801(a)(3); MISBRANDING   The article appears to be a device and the requirements under 518 or to furnish any material or information required by or under section 519 respecting a device were not met.