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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 AEK-8012363-7/1/4

Manufacturer FEI3007109797
Manufacturer Address line 1PACCA GARAH KASMIR ROAD  
Manufacturer Address line 2  
Manufacturer's CitySIALKOT  
Manufacturer Province/State  
Manufacturer Country/AreaPakistan  
Product Code76EIG  
FDA Product DescriptionRETRACTOR, ALL TYPES  
Refusal Date30-Aug-2010  
FDA DistrictNYK-DO  
Entry/doc/line/sfx AEK-8012363-7/1/4
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.