Bioelectronics Corp (BIEL)

[Hinsk]

Just stating the difference between 510K and PMAs. An area I deal with, never made a claim one is better for sales so take a deep breath just pointing out the difference why one might cost 2.5 k and the other 90k application fee from a regulatory standpoint. 510k is also used to demonstrate substantial equivalent to a predicate device. This is most likely the reason Biel went the 510k route plus a 90 day review period compared to a 180 day period