Replies to post #115256 on Bioelectronics Corp (BIEL)

[uksausage]

AFAIK there is no new 501K's

the old one was for general clearance and they got cleared for 2.

Is this one still open?

has anyone asked the FDA if it is still open?

We need some clarity the company has said nothing about FDA processes since the clearance letter which didnt imply there was anything left to wait for.

We just need some clarity on the situation