how important is fda 510k clearance, page-4

Rock Fish,

Please don't take this personally and none of the following is directed directly at you, but can everyone please stop asking whether FDA approval has been applied for.... The answer is NO. There are a few steps that have to be taken (i.e sales success in the Mexico market) before the application is placed. HGR is no doubt going places, its just a matter of time. It may be a day, a week, a month or even longer, but if you are a day trader, to be honest, I don't really care too much how you end up on a personal note. If you are in for the long haul, well, it doesn't matter when you buy in as long as your not too late as it's going to happen at some point in the near future.

Cheers all.