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Wednesday, September 10, 2008 10:39:38 PM
What I am interested most regarding your posting has to do with the comments on the Class III devices. Thanks for sharing your DD, which prompted me to review some items here.
It is my understanding that this 10-KSB/A is an amended filing done on 09/09/2008, which covers the year 2007. Please note that this amended document may contain corrections with no material changes to the original 10-KSB that was filed on 03/31/2008, which covers the same year 2007. However, I have not completely studied this amended filing to see what has been addressed and what amendment it has to the original filing.
I did review the recent amended filing of the 10-KSB/A with respect to your mention of the Class III devices information that is located under the section of GOVERNMENT REGULATORY APPROVAL PROCESS. And, I have compared this section with the original filing and note no difference in the wording, which appears to be the same.
Another step was taken to review the 10-KSB that was filed on 04/10/2007, which covers the year 2006. The section under GOVERNMENT REGULATORY APPROVAL PROCESS does not appear to indicate any change from the two latter filings. Therefore, I believe that this section of the Annual Report has not changed, at least, in the last two years.
These annual filings under the section of GOVERNMENT REGULATORY APPROVAL PROCESS that cover information on the Class III devices, also include information on PMA's, Class II devices, 510-K, Product Code IZG (System, X-ray, Photofluorographic) & Product Code IZL (System, X-ray, Mobile).
Included are the links for anyone interested in reviewing and comparing this information.
10-KSB/A filed on 09/09/2008:
http://www.pinksheets.com/edgar/GetFilingHtml?FilingID=6144799
10-KSB filed on 03/31/2008:
http://www.pinksheets.com/edgar/GetFilingHtml?FilingID=5834196
10-KSB filed on 04/10/2007:
http://www.pinksheets.com/edgar/GetFilingHtml?FilingID=5096430
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