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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 XXX-0174073-8/2/3


Manufacturer FEI3008455163
Manufacturer NameMedelkom Ltd  
Manufacturer Address line 1V A Graiciuno G 10  
Manufacturer Address line 2  
Manufacturer's CityVilnius  
Manufacturer Province/StateVilniaus  
Manufacturer Country/AreaLithuania  
Product Code85HEX  
FDA Product DescriptionCOLPOSCOPE (AND COLPOMICROSCOPE)  
Refusal Date14-Sep-2010  
FDA DistrictFLA-DO  
Entry/doc/line/sfx XXX-0174073-8/2/3
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.  
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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