Bioelectronics Corp (BIEL)

[DewmBoom]

“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

Special 510K, 30 days
Abbreviated 510k, 60 days
Satandard 510K, 90 days

Expedited 510K, should be no more than 15 days after submittal. The only missing information is the date when Biel submitted.

http://www.bielcorp.com/bioelectronics-receives-fda-pre-submission-approval-for-its-relief-of-musculoskeletal-pain-market-clearance-application/