The second option is a standard 510(k) submission resulting in a not substantially equivalent (NSE) decision by FDA reviewers. Following the NSE, you have 30 days to submit a de novo petition.
Here is the problem "investors" from last year had. Jim FAILED to submit within 30 days. He was so busy it took 10 months. Lots of paperwork came across his desk I guess.
Anybody have an answer about this?
Read the board from the point when the 510k was denied. Jim disappeared.
Lets use logic now. If this was a SURE thing after the 510k was denied and the longs sat through that, then WHY would they disappear along with Jim. Wait it out, approval is coming.....right? PM any of the longs of past if you want some insight. You won't like what you're going to hear.
News 
Market Data 
Discover 
