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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 N76-0162418-2/56/1

Manufacturer FEI3002993068
Manufacturer NameArburg Machinenfabrik Hehl & Sohne Gmbh & Co.Kg  
Manufacturer Address line 1Arthur-Hehl-Strasse  
Manufacturer Address line 2  
Manufacturer's CityLo?burg  
Manufacturer Province/StateBaden-wurttemberg  
Manufacturer Country/AreaGermany  
Product Code94V07  
Importer's Product DescriptionMONOCHROME MONITOR  
Refusal Date26-Sep-2006  
FDA DistrictNYK-DO  
Entry/doc/line/sfx N76-0162418-2/56/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NO REGISTR   536(a); Failure to file initial report   The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).