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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 112-1589164-9/1/1

Manufacturer FEI3004024657
Manufacturer NameResonant Light Technology Inc  
Manufacturer Address line 14875 N Island Highway  
Manufacturer Address line 2  
Manufacturer's CityCourtenay  
Manufacturer Province/StateBC  
Manufacturer Country/AreaCanada  
Product Code85KOH  
Importer's Product Description843806847509/OB-GYN DEVICE  
Refusal Date05-Dec-2003  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-1589164-9/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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).