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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 EQ6-0004503-1/1/1


Manufacturer FEI5833
Manufacturer NameEPPENDORF AG  
Manufacturer Address line 1Barkhausenweg 1  
Manufacturer Address line 2  
Manufacturer's CityHamburg  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code80LDQ  
FDA Product DescriptionDEVICE, GENERAL MEDICAL  
Refusal Date05-Dec-2005  
FDA DistrictFLA-DO  
Entry/doc/line/sfx EQ6-0004503-1/1/1
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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