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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 XXX-0135235-1/1/2


Manufacturer FEI3005170615
Manufacturer NameTerumo Medical Corporation  
Manufacturer Address line 1Unknown  
Manufacturer Address line 2  
Manufacturer's CityElkton  
Manufacturer Province/StateMD  
Manufacturer Country/AreaUnited States  
Product Code80FMF  
FDA Product DescriptionSYRINGE, PISTON  
Refusal Date28-Dec-2005  
FDA DistrictFLA-DO  
Entry/doc/line/sfx XXX-0135235-1/1/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
REGISTERED   502(o), 801(a)(3); MISBRANDING   It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).  
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