Replies to post #32272 on CSMG Technologies, Inc (fka CTGI)

[lowman]

Thanx ninja, I was beginning to think I was 'hyping' mistruths. As per the link you provided,

"Looking forward, we have identified 12 procedure-specific divisions, but only established subsidiaries for the first five we regard as closest to product and market completion...

and


...Significantly, in June we announced that our Ukraine partner, International Association Welding ("IAW"), had received approval for surgical welding devices for sale in Russia. Approval was granted by the Russian Federal Service of Health Care and Social Development for a tissue welding electro surgery generator and eight instruments for use in Russian hospitals and clinics. The approval is for a wide range of procedures the electro-surgical tissue welding generator and ancillary instruments can perform."


Interestingly, Ukraine has 8 functioning, Russian approved instruments. No doubt, we have access to those same instruments. No design engineering required. Ready for 510K submission. I wonder how many in total may be ready for 510K submission?

[rocketeer357]

Do you think all 12 of these apps will be covered by simple 510k filings or will they require clinical trials before FDA approval?