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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 EJ8-1123150-8/5/1


Manufacturer FEI3003751972
Manufacturer NameNINGBO HAIXIN IMPORT AND EXPORT CO.,LTD.  
Manufacturer Address line 1Beitang development zone, Juexi,  
Manufacturer Address line 2Xiangshan, Ningbo  
Manufacturer's CityNingbo  
Manufacturer Province/StateZhejiangsheng  
Manufacturer Country/AreaChina  
Product Code77KMA  
FDA Product DescriptionIRRIGATOR, POWERED NASAL  
Refusal Date17-Nov-2011  
FDA DistrictSAN-DO  
Entry/doc/line/sfx EJ8-1123150-8/5/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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).  
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).  
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