• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail
-

Refusal Details as Recorded in OASIS by FDA

for Refusal 310-5958077-4/1/1


Manufacturer FEI3003775404
Manufacturer NameBioptron AG  
Manufacturer Address line 1Gewerberpark Rohrbuel,  
Manufacturer Address line 2Sihleggstrasse 23  
Manufacturer's CityWollerau  
Manufacturer Province/State  
Manufacturer Country/AreaSwitzerland  
Product Code89NHN  
Importer's Product DescriptionLIGHT THERAPY LAMP FOR USE IN PAIN THERAPY  
Refusal Date28-Feb-2003  
FDA DistrictCIN-DO  
Entry/doc/line/sfx 310-5958077-4/1/1
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.  
-
-