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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 112-4305508-9/1/1


Manufacturer FEI3007539302
Manufacturer NameFOSHAN NANHAI NEW FACE BEAUTY INSTRUMENT FACTORY  
Manufacturer Address line 1SONGJIANG INDUSTRIAL ZONE, HENGJIANG  
Manufacturer Address line 2YANBU, NANHAI  
Manufacturer's CityFOSHAN  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code79GED  
Importer's Product Description503321555021 DERMABRASION MACHINE  
Refusal Date04-Nov-2011  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 112-4305508-9/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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