Re: FDA Reclassification Summary WRONG on everything.
All the companies that I know of are well on their way.
Ergoline
UWE
KBL
Heartland
Suncapsule
and more
These alone count for probably 90% of the units sold in the commercial arena.
The 510K process in pretty painless. No company will have to reduce their units output at all.
Please stop posting completely false and misleading information. |