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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 032-0416829-2/1/1


Manufacturer FEI3009141843
Manufacturer NameNingbo Hiking Import And Export Co Ltd  
Manufacturer Address line 1Rm 1502 0504 Building 668 Liangjialu  
Manufacturer Address line 2  
Manufacturer's CityNingboshi  
Manufacturer Province/StateZhejiangsheng  
Manufacturer Country/AreaChina  
Product Code76ECG  
Importer's Product DescriptionCLEANING MACHINE FOR INSTRUMENTS  
Refusal Date30-Nov-2011  
FDA DistrictFLA-DO  
Entry/doc/line/sfx 032-0416829-2/1/1
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.  
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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