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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 AEK-8895493-4/1/1

Manufacturer FEI3009166083
Manufacturer NameJapan Long-Tie  
Manufacturer Address line 11-2-1001 6666 Bi-Huan South Rd  
Manufacturer Address line 2  
Manufacturer's CityJinan  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code85HIS  
FDA Product DescriptionCONDOM  
Refusal Date04-Nov-2011  
FDA DistrictCIN-DO  
Entry/doc/line/sfx AEK-8895493-4/1/1
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.  
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).