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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 NS1-0006932-8/1/3

Manufacturer FEI3005343391
Manufacturer NameTuttnauer Ltd  
Manufacturer Address line 1Har Tuv B Industrial Zone  
Manufacturer Address line 2  
Manufacturer's CityBeit Shemesh  
Manufacturer Province/State  
Manufacturer Country/AreaIsrael  
Product Code80MED  
Importer's Product DescriptionLABORATORY AUTOCLAVE TTA3870-1R38EL  
Refusal Date02-Mar-2011  
FDA DistrictFLA-DO  
Entry/doc/line/sfx NS1-0006932-8/1/3
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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).