Bioelectronics Corp (BIEL)

[GetSeriousOK]

Yes, there has to be a "first for anything" with the FDA, but it has to be a PMA or a de novo -- it cannot, by definition, be a 510(k).

"Predicate device" is not nonsense or made of straw. It is a very specific thing. The FDA website has very good explanations of the 510(k) process and predicate devices.