Exhibit
      10.5

     

     

    
      	DEPARTMENT
              OF HEALTH & HUMAN SERVICES	
              Public
                Health
                Service

            


    

     

    
      	 	
              Food
                and Drug Adminstration

              9200
                Corporate Boulevard

              Rockville
                MD 20850

            


    

    
       

    

    
      
        	Mr. David J. Swanberg
Chief
                Operations Officer
IsoRay, Inc.
350 Hills Street, Suite
                106
RICHLAND WA 99352	
                Re: 
                  K030162

                Trade/Device
                  Name: Lawrence CSERION

                Model
                  CS-1

                Regulation
                  Number: 21 CFR 892.5730

                Regulation
                  Name: Radionuclide

                brachytherapy
                  source

                Regulatory
                  Class: II

                Product
                  Code: 90 KXK

                Dated:
                  January 13, 2003

                Received:
                  January 16,
                  2003

              


      

    

        

    Dear
      Mr.
      Swanberg:

    


    We
      have
      reviewed your Section 510(k) premarket notification of intent to market the
      device referenced above and have determined the device is substantially
      equivalent (for the indications for use stated in the enclosure) to legally
      marketed predicate devices marketed in interstate commerce prior to May 28,
      1976, the enactment date of the Medical Device Amendments, or to devices that
      have reclassified in accordance with the provisions of the Federal Food, Drug,
      and Cosmetic Act (Act) that do not require approval of a premarket approval
      application (PMA). You may, therefore, market the device, subject to the general
      controls provisions of the Act. The general controls provisions of the Act
      include requirements for annual registration, listing of devices, good
      manufacturing practice, labeling, and prohibitions against misbranding and
      adulteration. 

    


    If
      your
      device is classified (see above) into either Class II (Special Controls) or
      Class III (PMA), it may be subject to additional controls. Existing major
      regulations affecting your device can be found in the Code of Federal
      Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further
      announcements concerning your device in the Federal
      Register.

    


    Please
      be
      advised that FDA’s issuance of a substantial equivalence determination does not
      mean that FDA has made a determination that your device complies with other
      requirements of the Act or any Federal statutes and regulations administered
      by
      other Federal agencies. You must comply with all the Act’s requirements,
      including, but not limited to: registration and listing (21 CFR Part 807);
      labeling (21 CFR Part 801); good manufacturing practice requirements as set
      forth in the quality systems (QS) regulation (21 CFR Part 820); and if
      applicable, the electronic product radiation control provisions (sections
      531-542 of the Act); 21 CFR 1000-1050. 

    


    This
      letter will allow you to begin marketing your device as described in your
      Section 510(k) premarket notification. The FDA finding of substantial
      equivalence of your device to a legally 

    marketed
      predicate device results in a classification for your device and thus, permits
      your device to the proceed to the market.

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
Page
      2

     

    If
      you
      desire specific advice for your device on our labeling regulation (21 CFR Part
      801), please contact the Office of Compliance at one of the following numbers,
      based on the regulation number at the top of the letter:

    


    
      
        	 	
                8xx.1xxx

                876.2xxx, 3xxx, 4xxx, 5xxx

                884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx

                892.2xxx, 3xxx, 4xxx, 5xxx

                Other

              	
                (301)
                  594-4591

                (301) 594-4616

                (301) 594-4616

                (301)
                  594-4654

                (301)
                  594-4692

              


      
   

    Additionally,
      for questions on the promotion and advertising of your device, please contact
      the Office of Compliance at (301) 594-4639. Also, please note the regulation
      entitled “Misbranding by reference to premarket notification” (21 CFR Part
      807.97) you may obtain. Other general information on your responsibilities
      under
      the Act may be obtained from the Division of Small Manufacturers, International
      and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597
      or its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html.

     

    
      	 	 	 
	 	Sincerely
              yours,
	 	 
	 	
              /s/ Nancy C. Brogdon

              Director, Division of Reproductive,

              Abdominal and Radiological Devices

              Office of Device Evaluation

              Center for Devices and Radiological
                Health

            



     

    Enclosure