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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-6996266-6/1/1


Manufacturer FEI3003844452
Manufacturer NameFianim Enterprises  
Manufacturer Address line 1Wazirabad Road, Ugoki  
Manufacturer Address line 2  
Manufacturer's CitySialkot  
Manufacturer Province/State  
Manufacturer Country/AreaPakistan  
Product Code79GEN  
FDA Product DescriptionFORCEPS, GENERAL & PLASTIC SURGERY  
Refusal Date14-Jan-2005  
FDA DistrictNYK-DO  
Entry/doc/line/sfx AEK-6996266-6/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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