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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 109-0813331-6/13/1

Manufacturer FEI3006447043
Manufacturer NameBina Limited  
Manufacturer Address line 1Commercial Free Zone  
Manufacturer Address line 2  
Manufacturer's CityCorozal  
Manufacturer Province/State  
Manufacturer Country/AreaBelize  
Product Code76EMN  
FDA Product DescriptionSCALER, PERIODONTIC  
Refusal Date08-Sep-2010  
FDA DistrictFLA-DO  
Entry/doc/line/sfx 109-0813331-6/13/1
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).