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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 DM9-5011639-0/2/1

Manufacturer FEI3005445083
Manufacturer NameOlsen Industria E Comercio S.A.  
Manufacturer Address line 1Rua Ivo Luchi 68-Distro Industrial  
Manufacturer Address line 2  
Manufacturer's CityPalhoca  
Manufacturer Province/State  
Manufacturer Country/AreaBrazil  
Product Code80LGX  
Refusal Date21-Dec-2005  
FDA DistrictFLA-DO  
Entry/doc/line/sfx DM9-5011639-0/2/1
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.  
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).