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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 231-2875095-9/40/1

Manufacturer FEI1000584424
Manufacturer NameFranz Kalff Gmbh  
Manufacturer Address line 1Postfach 4140  
Manufacturer Address line 2  
Manufacturer's CityEuskirchen  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code79LRR  
FDA Product DescriptionKIT, FIRST AID  
Refusal Date21-Jan-2005  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 231-2875095-9/40/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).