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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 275-1421292-0/8/1

Manufacturer FEI2016150
Manufacturer NameOrmco/Sybronendo  
Manufacturer Address line 11332 S Lone Hill Ave  
Manufacturer Address line 2  
Manufacturer's CityGlendora  
Manufacturer Province/StateCA  
Manufacturer Country/AreaUnited States  
Product Code76EKM  
FDA Product DescriptionGUTTA-PERCHA  
Refusal Date23-Sep-2010  
FDA DistrictLOS-DO  
Entry/doc/line/sfx 275-1421292-0/8/1
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).