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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 750-0138477-7/1/40

Manufacturer FEI3002138952
Manufacturer NameM/S. Mibe Corporation  
Manufacturer Address line 1Marala Road, Gohadpur  
Manufacturer Address line 2  
Manufacturer's CitySialkot  
Manufacturer Province/State  
Manufacturer Country/AreaPakistan  
Product Code76EIG  
FDA Product DescriptionRETRACTOR, ALL TYPES  
Refusal Date20-Aug-2010  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 750-0138477-7/1/40
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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.