Replies to post #147192 on Bioelectronics Corp (BIEL)

[DewmBoom]

You can do anything you want but I am sharing with you factual information. They will know they get clearance is when the FDA issues a letter.

[DewmBoom]

We knew from before that the 510K was traditional. So what you found out is not new. However, the 90 days are for traditional 510K that requires full review. BIEL’s 510K does not require a full review.

The answer they gave you is correct. The 90 days is the maximum number of days it takes for a traditional 510K.