Bioelectronics Corp (BIEL)

[Chyna9]

Yes, correct. If they are accepted, then a 510k would follow.

Problem is, that should have already happened (the 510k). Long time ago now.

Read back, the story was that they were doing two 510k, one for actipatch, one for RR. They pulled rr off the table and entered it into the challenge instead. It was a bait and switch imo. It was built into the pps that it was coming. One of many reasons pps hasn't been doing well.

Hope it gets accepted. Will be glad for you if so.