Bioelectronics Corp (BIEL)

[DewmBoom]

Special 510K, 30 Days
Abbreviated 510K, 60 Days
Standard 510K, 90 Days

Read a quote from the press release after the May 9 Biel meeting with the FDA. It says EXPEDITED, and this means 30 days to me. As a matter of fact, I would approve it tomorrow or next week after the Many Many Many Years of waiting. They already reviewed the data during the pre-meeting.

QUOTE:

Dr. Koneru, who led the discussion, expressed confidence in the FDA’s constructive feedback. “We are pleased that the FDA viewed our data and statistical methods favorably. They have provided guidance on how to combine the back-pain study results, along with our previously cleared 510(k), into a single 510(k) submission for obtaining expedited expanded market clearance.”, he said.