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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-0174028-2/1/1


Manufacturer FEI3003775311
Manufacturer NameUNKNOWN  
Manufacturer Address line 1UNK  
Manufacturer Address line 2  
Manufacturer's CityNo Where  
Manufacturer Province/StateND  
Manufacturer Country/AreaUnited States  
Product Code76EAZ  
FDA Product DescriptionLIGHT, OPERATING, DENTAL  
Refusal Date03-Sep-2010  
FDA DistrictATL-DO  
Entry/doc/line/sfx XXX-0174028-2/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
LACKS FIRM   502(b)(1), 801(a)(3); MISBRANDING   The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.  
NO REGISTR   536(a); Failure to file initial report   The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).  
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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