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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 UPS-9112401-4/7/1

Manufacturer FEI3008347107
Manufacturer NameMiracle International Co. Ltd  
Manufacturer Address line 1Huanshi 205 Qilinzhonglu  
Manufacturer Address line 2  
Manufacturer's CityYanzhoushi  
Manufacturer Province/StateYandongsheng  
Manufacturer Country/AreaChina  
Product Code89ISA  
Refusal Date25-Aug-2010  
FDA DistrictNYK-DO  
Entry/doc/line/sfx UPS-9112401-4/7/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NO 510(K)   801(a)(3); 502(o) Misbranding   It appears that a notice or other information respecting the device was not provided to FDA, as required by Section 510(k) and the device was not found to be substantially equivalent to a predicate device.