Replies to post #140964 on Bioelectronics Corp (BIEL)

[TAZZER]

The way the 510K process works they submit it usually two weeks later FDA sets up a pre submission meeting to provide guidance on your 510K you submitted. If they are good with the 510K they approve the submission. So for both cases they already filed the 510K and they are being expedited.

[DewmBoom]

PREVIOUSLY SUBMITTED 510K

QUOTE:

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.

BioElectronics Receives FDA Pre-Submission Approval for its Relief of Musculoskeletal Pain Market Clearance Application https://finance.yahoo.com/news/bioelectronics-receives-fda-pre-submission-123000275.html