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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 906-1029871-4/1/9

Manufacturer FEI3003340857
Manufacturer NameMua Ortho Dentics Supply  
Manufacturer Address line 1P.O. Box 2328, Nasir Road  
Manufacturer Address line 2  
Manufacturer's CitySialkot  
Manufacturer Province/State  
Manufacturer Country/AreaPakistan  
Product Code76EJB  
Refusal Date11-Aug-2010  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 906-1029871-4/1/9
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis Yes  
Violation Code Section Charge Statement
STAINSTEEL   501(c); 801(a)(3) Adulteration   The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.