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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 T76-0826036-2/1/1


Manufacturer FEI3002859514
Manufacturer NameDavid Biotech Limited  
Manufacturer Address line 1Western Side, Sougshan Road  
Manufacturer Address line 2  
Manufacturer's CityShantou  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code85LHD  
FDA Product DescriptionDEVICE, FERTILITY DIAGNOSTIC  
Refusal Date30-Dec-2003  
FDA DistrictLOS-DO  
Entry/doc/line/sfx T76-0826036-2/1/1
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.  
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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