Bioelectronics Corp (BIEL)

[markjohn62]

DaytimeL, The original 510k was a traditional and this is an added indication tacked on the to previous traditional one.


Sree Koneru--

The 510(k) that was filed does combine indications from the previous 510(k), which is why we are asking for "expanded" indications. The word "traditional" in the 510(k) is just to indicate the type of application prepared, as there are only three types. Seeking expanded indications automatically requires a "traditional" 510(k), since the other two types are for device modifications etc.