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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 FR1-0013729-3/4/1

Manufacturer FEI3002807710
Manufacturer NameNipro Corporation - Ohdate Factory  
Manufacturer Address line 18-7, Hanukiyachi, Niida-Aza  
Manufacturer Address line 2  
Manufacturer's CityOdate, Akita  
Manufacturer Province/State  
Manufacturer Country/AreaJapan  
Product Code78FJI  
Importer's Product DescriptionDIALYZER FOR EXPORT ONLY  
Refusal Date04-Mar-2011  
FDA DistrictFLA-DO  
Entry/doc/line/sfx FR1-0013729-3/4/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NO 510(K)   801(a)(3); 502(o) Misbranding   It appears that a notice or other information respecting the device was not provided to FDA, as required by Section 510(k) and the device was not found to be substantially equivalent to a predicate device.  
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